Angezeigte Tests zum neuartigen Coronavirus (SARS-CoV-2) in Deutschland und Europa
Mehr Informationen zu dieser Tabelle und zu Tests auf SARS-CoV-2 finden Sie unter
Informationen über Tests zum neuartigen Coronavirus (SARS-CoV-2)
Tabelle über in Deutschland angezeigte Tests zu SARS-CoV-2
Bitte beachten Sie: Die Liste enthält ausschließlich Tests, die bereits von den zuständigen Behörden registriert wurden. Darüber hinaus gibt es ggf. offene Anzeigen, die noch von den zuständigen Behörden bearbeitet werden und daher nicht in dieser Liste enthalten sind. Weiterhin enthalten unsere Datenbanken formale Angaben und keine technischen und inhaltlichen Informationen zu den Tests. Aufgrund der gemeinsamen europäischen Rechtsgrundlage dürfen zudem auch Tests auf den deutschen Markt, die in einem anderen europäischen Mitgliedsstaat registriert sind. Diese sind in der Datenbank nicht enthalten.
Um innerhalb der Tabelle zu suchen, nutzen Sie einfach die Tastenkombination STRG + F. Für mehr Informationen und komfortablere Recherche- und Filtermöglichkeiten können Sie eine Pauschale für die Recherche in öffentlichen Datenbanken erwerben:
* Anzeigepflichtig nach § 5 Medizinproduktegesetz (MPG) ist der Hersteller oder sein Bevollmächtigter bzw. Einführer.
Stand: 24.09.2021, Anzahl der Ergebnisse: 1207
| Dokument-nummer | Registrier-datum | Anzeigepflichtiger* in Deutschland | Hersteller außerhalb Deutschlands | Staat des Herstellers | Handelsname (HN), Allgemeine Produktbezeichnung (AP) |
|---|---|---|---|---|---|
| 00101574 | 2021-09-22 | Share Info GmbH | Nanjing Leading Medical Technology Co., Ltd. | China | HN: SARS-CoV-2 Neutralizing Antibody Detection Kit (Latex immunochromatography-sandwich method) |
| 00098101 | 2021-09-22 | Dr. Muche GmbH | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clungene® Covid-19 Antigen Rapid Test AP: Covid-19 Antigen Rapid Test |
| 00097684 | 2021-09-22 | DAR GmbH | Shenzhen Lvshiyuan Biotechnology Co.,Ltd | China | AP: Covid-19 Schnelltest |
| 00097171 | 2021-09-22 | MegaCor GmbH | SA Scientific LTD | Vereinigte Staaten von Amerika | HN: SAS COVID-19 IgM/IgG ANTIBODY DETECTION TEST |
| 00097159 | 2021-09-22 | MegaCor GmbH | SA Scientific Ltd. | Vereinigte Staaten von Amerika | HN: SAS COVID-19 Total ANTIBODY DETECTION TEST |
| 00096459 | 2021-09-22 | MedPath GmbH | Zhengzhou Affinity Biosciences Co., Ltd. | China | HN: Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit |
| 00095542 | 2021-09-22 | MedPath GmbH | Zhuhai Haitai Biological Pharmaceutical Co., Ltd. | China | HN: Novel Coronavirus (SARS-CoV-2) ORF1ab/N gene Detection Kit (Real-time fluorescent PCR) |
| 00095540 | 2021-09-22 | MedPath GmbH | Hunan Yonghe-sun biotechnology Co., Ltd | China | HN: Novel coronavirus (SARS-CoV-2) specific antibody test kit (immunochromatographic assay) |
| 00095537 | 2021-09-22 | MedPath GmbH | Jiangsu MDK Biotech Co., Ltd. | China | HN: 2019-nCoV IgG/IgM antibody rapid test cassette (Immunochromatographic Assay) |
| 00095370 | 2021-09-22 | MedPath GmbH | Zhuhai Haitai Biological Pharmaceutical Co., Ltd. | China | HN: Novel coronavirus (SARS-CoV-2) ORF1ab/N gene/influenza A/influenza B detection kit(Real-time fluorescent PCR) |
| 00101254 | 2021-09-21 | Icon Medlab GmbH | Xiamen Boson Biotech Co., Ltd | China | HN: ANTI-SARS-COV-2 S PROTEIN ANTIBODY TEST CARD |
| 00099745 | 2021-09-03 | Vicare Solution GmbH | HN: VICARE RAPID FL SARS-CoV-2 Test-Kit | ||
| 00101478 | 2021-09-16 | MP Biomedicals Germany GmbH | MP Biomedicals Asia Pacific Pte. Ltd. | Singapur | HN: Rapid SARS-CoV-2 Antigen Test Card |
| 00101305 | 2021-09-16 | Luxus Lebenswelt GmbH | Shanghai Bionaire Biotech Co., Ltd. | China | HN: Novel Coronavirus (COVID-19) Antibody (IgM/IgG) Test AP: Novel Coronavirus (COVID-19) Antibody (IgM/IgG) Test |
| 00101301 | 2021-09-15 | MedNet EC-REP GmbH | TaiDoc Technology Corporation | Taiwan | HN: VTRUST TD-4532 AP: SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody) |
| 00101275 | 2021-09-16 | Luxus Lebenswelt GmbH | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. | China | HN: DEEPBLUE AP: COVID-19 (Sars-CoV-2) Antigen Test Midstream - Saliva |
| 00101392 | 2021-09-13 | Osmunda Medical Technology Service GmbH | GenSure Biotech Inc. | China | HN: GenSure COVID-19 Antigen Rapid Test Kit |
| 00100491 | 2021-08-26 | PureMDR GmbH | Shenzhen Yilifang Biotechnology Co., Ltd. | China | HN: COVID-19 Antigen Test Kit (Colloidal Gold) |
| 00101297 | 2021-09-10 | Ruiyi Healthcare GmbH | MSB Medical (Wuhan) Co., Ltd. | China | HN: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit (Immunochromatography/Colloidal Gold) AP: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit (Immunochromatography/Colloidal Gold) |
| 00101285 | 2021-09-10 | Ruiyi Healthcare GmbH | MSB Medical (Wuhan) Co., Ltd. | China | HN: Covid-19(SARS-CoV-2) Antigen Rapid Test Kit (Immunochromatography) AP: Covid-19(SARS-CoV-2) Antigen Rapid Test Kit (Immunochromatography/Colloidal Gold) |
| 00101159 | 2021-09-08 | Medical Device Safety Service GmbH | PlexBio Co., Ltd. | Taiwan | HN: IntelliPlex™ SARS-CoV-2 Test Control Kit |
| 00101296 | 2021-09-06 | Genome Identification Diagnostics GmbH | HN: CoV-iSpot pure | ||
| 00101295 | 2021-09-06 | mdi Europa GmbH | Eternal Materials Co., Ltd. | Taiwan | AP: Coronavirus RT & POC |
| 00101188 | 2021-09-06 | KTR Europe GmbH | COSMAXPHARMA | Korea, Rep. | HN: iDetect-2 SARS-CoV-2 Real-time PCR Kit |
| 00100825 | 2021-09-06 | Genome Identification Diagnostics GmbH | HN: SARS-CoV-2 MutaScreen21.2 | ||
| 00100790 | 2021-09-03 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) |
| 00100546 | 2021-09-03 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: SARS-CoV-2 RT-PCR Assay |
| 00101251 | 2021-09-01 | Medical Technology Promedt Consulting GmbH | 3B BlackBio Biotech India Ltd. | Indien | HN: TRURAPID® COVID-19 Ag Test - Version 3.0 |
| 00101250 | 2021-09-02 | Luxus Lebenswelt GmbH | Shanghai Bionaire Biotech Co., Ltd. | China | HN: Novel Coronavirus (COVID-19) Neutralizing Antibodies Test (Colloidal Gold) AP: Novel Coronavirus (COVID-19) Neutralizing Antibodies Test (Colloidal Gold) |
| 00101198 | 2021-09-01 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA) AP: SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA) |
| 00101197 | 2021-09-01 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: 2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method) AP: 2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method) |
| 00101101 | 2021-09-23 | Medical Device Safety Service GmbH | DiaCarta, Inc. | Vereinigte Staaten von Amerika | HN: QuantiVirus™ SARS-CoV-2 Variants Detection Kit; QuantiVirus™ SARS-CoV-2 Delta+ Detection Kit |
| 00101071 | 2021-09-01 | Medical Device Safety Service GmbH | Diazyme Laboratories, Inc | Vereinigte Staaten von Amerika | HN: Diazyme SARS-Cov-2 Antigen Rapid Test Controls |
| 00101070 | 2021-09-01 | Medical Device Safety Service GmbH | Diazyme Laboratories, Inc | Vereinigte Staaten von Amerika | HN: Diazyme SARS-Cov-2 Antigen Rapid Test |
| 00100486 | 2021-08-31 | nal von minden GmbH | HN: NADAL® COVID-19 RBD-NAb Test | ||
| 00098969 | 2021-08-31 | nal von minden GmbH | HN: 243204N-20 NADAL® Covid Ag+Influenza A/B plus Test AP: Covid-19 Ag Test |
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| 00101147 | 2021-08-27 | Osmunda Medical Technology Service GmbH | Wuhan EasyDiagnosis Biomedicine Co., Ltd. | China | HN: COVID-19 (SARS-CoV-2) Antigen Test Kit |
| 00101093 | 2021-08-27 | NanoRepro AG | HN: NanoRepro SARS-CoV-2 Neutralisierende Antikörper Schnelltest AP: RAPID DIAGNOSTIC TEST |
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| 00100458 | 2021-08-26 | PureMDR GmbH | Yunnan Haoxu Biotechonology Ltd. | China | HN: 2019-nCoV Ag Rapid Test (Saliva) |
| 00100230 | 2021-08-26 | PureMDR GmbH | JINAN BABIO BIOTECHNOLOGY CO., LTD. | China | HN: SARS-CoV-2 Neutralization Antibody Test Kit (Colloidal Gold) AP: SARS-CoV-2 Neutralization Antibody Test Kit (Colloidal Gold) |
| 00095284 | 2021-08-25 | MedPath GmbH | Shanghai Outdo Biotech Co., Ltd. | China | HN: Novel Coronavirus (SARS-CoV-2) RNA Detection Kit (Real-time PCR) |
| 00101035 | 2021-08-24 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: Multiplex Real-Time PCR Detection Kit for 27 Species of Respiratory Pathogens AP: Multiplex Real-Time PCR Detection Kit for 27 Species of Respiratory Pathogens |
| 00101034 | 2021-09-02 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: 2019-nCoV Antigen Rapid Test Cassette AP: 2019-nCoV Antigen Rapid Test Cassette |
| 00101033 | 2021-09-02 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: 2019-nCoV Antigen Rapid Test Cassette AP: 2019-nCoV Antigen Rapid Test Cassette |
| 00101032 | 2021-09-02 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: 2019-nCoV Antigen Rapid Test Cassette AP: 2019-nCoV Antigen Rapid Test Cassette |
| 00101031 | 2021-09-01 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: Multiple Real-Time PCR Kit for Detection of 2019-nCoV AP: Multiple Real-Time PCR Kit for Detection of 2019-nCoV |
| 00101030 | 2021-08-24 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: 6 Respiratory Pathogen Antigens Rapid Test Cassette (Colloidal Gold Method) AP: 6 Respiratory Pathogen Antigens Rapid Test Cassette (Colloidal Gold Method) |
| 00100907 | 2021-08-24 | Luxus Lebenswelt GmbH | Jiangsu Baozhilin Medical Technology Co., Ltd | China | HN: SARS-CoV-2 Neutralizing Antibody Rapid Test kits (Colloidal Gold) AP: SARS-CoV-2 Neutralizing Antibody Rapid Test kits (Colloidal Gold) |
| 00100906 | 2021-08-24 | Luxus Lebenswelt GmbH | Jiangsu Baozhilin Medical Technology Co., Ltd | China | HN: SARS-CoV-2 IgG/IgM rapid test kits (Golloidal Gold) AP: SARS-CoV-2 IgG/IgM rapid test kits (Golloidal Gold) |
| 00100652 | 2021-08-24 | Caretechion GmbH | 3D Biomedicine Science & Technology Co., Limited | China | AP: ANDiS FAST SARS-CoV-2 RT-qPCR Detection kit |
| 00099811 | 2021-08-24 | Luxus Lebenswelt GmbH | Shenzhen Lvshiyuan Biotechnology Co., Ltd. | China | HN: Quality Control Product for SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold) AP: Quality Control Product for SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold) |
| 00101180 | 2021-08-23 | JaviTech e.K. | Genes Laboratories | Korea, Rep. | HN: GCdia™ COVID-19 Fast Detection Kit AP: Novel Coronavirus detection kit |
| 00101110 | 2021-08-23 | Share Info GmbH | Guangdong Hecin Scientific, Inc. | China | HN: 2019-nCoV and Delta Strain Nucleic Acid Test Kit (PCR- fluorescence probe method) |
| 00101154 | 2021-08-19 | Sysmex Europe GmbH | Sysmex Corporation | Japan | HN: HISCL SARS-CoV-2 S-IgG Control |
| 00101153 | 2021-08-19 | Sysmex Europe GmbH | Sysmex Corporation | Japan | HN: HISCL SARS-CoV-2 S-IgG Assay Kit |
| 00101150 | 2021-08-19 | Sysmex Europe GmbH | Sysmex Corporation | Japan | HN: HISCL SARS-CoV-2 S-IgG Calibrator |
| 00101014 | 2021-08-18 | BioeXsen GmbH | HN: BioeXsen SARS-CoV-2 Variant Plus V2 S2R | ||
| 00101013 | 2021-08-18 | BioeXsen GmbH | HN: BioeXsen SARS-CoV-2 Variant Plus V2 | ||
| 00099573 | 2021-08-19 | GA Generic Assays GmbH | HN: GA CoV-2 Antigen Rapid Nasal AP: 3987 |
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| 00101103 | 2021-08-16 | Medical Technology Promedt Consulting GmbH | BioMedomics, Inc. | Vereinigte Staaten von Amerika | HN: COVID-19 Antigen External Control Kit |
| 00101015 | 2021-08-16 | Dr. Fooke-Achterrath Laboratorien GmbH | HN: Anti-SARS-CoV-2-LFA IgG AP: Anti-SARS-CoV-2 IgG Bestimmung |
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| 00100836 | 2021-08-16 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clongene AP: COVID-19 Neutralization Antibody Rapid Test Cassette (WB/S/P) |
| 00100835 | 2021-08-16 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clongene AP: COVID-19 IgG Semi-Quantitative Rapid Test Cassette (WB/S/P) |
| 00099714 | 2021-08-13 | BIOTECON Diagnostics GmbH | HN: microproof® SARS-CoV-2 Identification Kit | ||
| 00099713 | 2021-08-13 | BIOTECON Diagnostics GmbH | HN: microproof® SARS-CoV-2 Screening Kit | ||
| 00100829 | 2021-08-11 | Medical Device Safety Service GmbH | Coyote Bioscience Co., Ltd. | China | HN: SARS-CoV-2 Ag Rapid Test Kit; SARS-CoV-2 Neutralizing Antibody Rapid Test Kit |
| 00100687 | 2021-08-11 | Medical Device Safety Service GmbH | CTK Biotech, Inc. | Vereinigte Staaten von Amerika | HN: RaFIA COVID-19 Ag FIA Test |
| 00100894 | 2021-08-10 | Bio-Gram Diagnostics Germany | HN: ImmunoCheck+ Corona Immunitätskontrolle AP: Blutentnahme Set |
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| 00100672 | 2021-08-23 | MedNet GmbH | ACON Biotech (Hangzhou) Co., Ltd. | China | HN: FlAflex SARS-CoV-2 & Influenza A/B Ag Combo FIA, Flowflex SARS-CoV-2 & Influenza A/B Ag Combo Rapid Test |
| 00099970 | 2021-08-09 | MedNet GmbH | Dewei Medical Equipment Co.,Ltd | China | HN: COVID-19 (2019-n-CoV) Nucleic Acid Detection Kit (PCR Fluorescence Probing) |
| 00100928 | 2021-08-05 | JaviTech e.K. | Biometro Co.,Ltd. | Korea, Rep. | HN: BM COVID-19 Ag Rapid Gold AP: COVID-19 Antigen Test Kit (Colloidal Gold) |
| 00100927 | 2021-08-05 | JaviTech e.K. | Biometro Co.,Ltd. | Korea, Rep. | HN: BM COVID-19 nAb Rapid Gold AP: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) |
| 00100877 | 2021-08-04 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 RBD Antibody Test kit (Immunochromatography) |
| 00100875 | 2021-08-04 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 Neutralizing Antibody Test kit (Immunochromatography) |
| 00100837 | 2021-08-05 | JaviTech e.K. | UNIANCE GENE Co., LTD. | Korea, Rep. | HN: UGDx COVID-19 Ag Rapid Test AP: COVID-19 Ag Rapid Kit |
| 00100820 | 2021-08-04 | MEXACARE GmbH | HN: Mexacare COVID-19 Antigen Schnelltest (Nasopharyngeal-, Oropharyngeal-, Nasalabstrich) | ||
| 00100583 | 2021-08-04 | Roche Diagnostics, GmbH | Roche Molecular Systems, Inc. | Vereinigte Staaten von Amerika | HN: cobas® Liat® SARS-CoV-2 Script for cobas® Liat® Analyzer |
| 00100582 | 2021-08-04 | Roche Diagnostics, GmbH | Roche Molecular Systems, Inc. | Vereinigte Staaten von Amerika | HN: cobas® SARS-CoV-2, cobas® SARS-CoV-2 Quality Control Kit (Liat) |
| 00098811 | 2021-08-04 | Osmunda Medical Technology Service GmbH | Shanghai Chemtron Biotech. Co., Ltd. | China | HN: Chemtrue® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold) |
| 00098810 | 2021-08-04 | Osmunda Medical Technology Service GmbH | Shanghai Chemtron Biotech. Co., Ltd. | China | HN: Chemtrue® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold) |
| 00098809 | 2021-08-04 | Osmunda Medical Technology Service GmbH | Shanghai Chemtron Biotech. Co., Ltd. | China | HN: Chemtrue® COVID-19/Influenza A+B Ag Combo Rapid Test (Colloidal Gold) |
| 00098805 | 2021-08-04 | Osmunda Medical Technology Service GmbH | Shanghai Chemtron Biotech. Co., Ltd. | China | HN: Chemtrue® COVID-19 Ag Rapid Test (Colloidal Gold) |
| 00095515 | 2021-08-04 | MEXACARE GmbH | HN: MEXACARE CORONA Antikörper Home-Test | ||
| 00100980 | 2021-08-03 | Share Info GmbH | Guangdong Hecin Scientific, Inc. | China | HN: 2019-nCoV Nucleic Acid Fast Testing |
| 00100468 | 2021-08-02 | MedNet EC-REP GmbH | Aikang Diagnostics Co., Ltd | China | HN: COVID-19 Neutralizing Antibody Test Kit(Sandwich Method) |
| 00100441 | 2021-08-02 | MedNet EC-REP GmbH | Artron Laboratories Inc. | Kanada | AP: COVID-19 Antigen Test (Saliva) |
| 00098844 | 2021-08-02 | GA Generic Assays GmbH | HN: GA CoV-2 Antigen Rapid Test AP: 3985 |
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| 00100830 | 2021-07-30 | BIORON GmbH | AO Vector-Best | Russische Föderation | HN: SARS-CoV-2-IgG quantitative-EIA-BEST |
| 00100951 | 2021-07-29 | Medical Technology Promedt Consulting GmbH | Solgent Co., Ltd. | Korea, Rep. | HN: DiaRapid™ COVID-19 Ag Test Kit |
| 00100163 | 2021-07-28 | MedNet EC-REP GmbH | Aikang Diagnostics Co., Ltd | China | HN: COVID-19 Antigen Test Kit (Immunochromatography) |
| 00099809 | 2021-07-28 | Luxus Lebenswelt GmbH | BeiJing Abace Biotechnology Co., Ltd. | China | HN: (2019-nCov) Novel Coronavirus Antigen Test Kit (Colloidal Gold Immunochromatography) AP: (2019-nCov) Novel Coronavirus Antigen Test Kit (Colloidal Gold Immunochromatography) |
| 00100900 | 2021-08-24 | Luxus Lebenswelt GmbH | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. | China | HN: COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold) AP: COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold) |
| 00100375 | 2021-07-26 | Luxus Lebenswelt GmbH | Shanghai Taisite bio-pharmaceutical Co. , Ltd | China | HN: Novel Coronavirus (COVID-19) Antigen Detection Kit AP: Novel Coronavirus (COVID-19) Antigen Detection Kit |
| 00099323 | 2021-07-26 | Medwheat Tech Service GmbH | HangZhou Lifereal biotechnology CO.,Ltd | China | HN: Instant Inactivated Virus Preservation Solution (A0006-EA, A0006-EB) |
| 00100858 | 2021-07-23 | DRG Instruments GmbH | HN: SARS-CoV-2 IgG ELISA | ||
| 00100883 | 2021-07-21 | Share Info Consultant Service LLC Repräsentanzbüro | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO.,LTD | China | HN: SARS-CoV-2 Neutralizing Antibody Detection Kit |
| 00100878 | 2021-09-02 | Share Info Consultant Service LLC Repräsentanzbüro | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO.,LTD | China | HN: SARS-CoV-2 Antigen Test kit |
| 00100794 | 2021-07-22 | Dräger Safety AG & Co. KGaA | HN: Dräger COVID-19 Home Test | ||
| 00100376 | 2021-07-20 | Luxus Lebenswelt GmbH | Shenzhen Lvshiyuan Biotechnology Co., Ltd. | China | HN: Quality control product for SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) AP: Quality control product for SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) |
| 00100138 | 2021-07-20 | Luxus Lebenswelt GmbH | Beijing Aeonview Co., Ltd. | China | HN: Aeonview AP: SARS-COV-2 Detection Kit |
| 00100819 | 2021-07-16 | MedNet GmbH | Hangzhou AllTest Biotech Co., Ltd. | China | HN: ALLTEST / Beright / JusChek / Lambra / SCREEN CHECK TEST / Rapid Response / Gruppo Si.Gi. SARS-CoV-2 Antigen Rapid Test (Nasal Swab) |
| 00099999 | 2021-07-16 | EUmediq GmbH | Chronomics Ltd | Vereinigtes Königreich | HN: SaliVIR Rapid Multiplex COVID19 vRNA Test AP: SaliVIR Rapid Multiplex COVID19 vRNA Test |
| 00100824 | 2021-07-15 | Medical Technology Promedt Consulting GmbH | ARISTA Biotech Pte. Ltd. | Singapur | HN: ARISTA™ COVID-19 Antigen Rapid Test AP: COVID-19 Antigen Svchnelltest zur Eigenanwendung |
| 00100307 | 2021-07-15 | Shanghai International Holding Corporation GmbH (Europe) | Healgen Scientific Limited Liability Company | Vereinigte Staaten von Amerika | HN: Healgen AP: Rapid COVID-19 Antigen Self-Test |
| 00100306 | 2021-07-15 | Shanghai International Holding Corporation GmbH (Europe) | Healgen Scientific Limited Liability Company | Vereinigte Staaten von Amerika | HN: Healgen AP: CLINITEST Rapid COVID-19 Antigen Self-Test |
| 00099543 | 2021-07-14 | MedNet EC-REP GmbH | Labnovation Technologies, Inc. | China | HN: SARS-CoV-2 Neutralizing Antibody Rapid Test Kit (Immunochromatography) |
| 00100798 | 2021-07-13 | Osmunda Medical Technology Service GmbH | Beijing Jinwofu Bioengineering Technology Co., Ltd. | China | HN: Novel Coronavirus(SARS-CoV-2) Antigen Rapid Test Kit |
| 00100797 | 2021-07-13 | Osmunda Medical Technology Service GmbH | Nantong Diagnos Biotechnology Co.,Ltd. | China | HN: COVID-19 Antigen Speichel-Test Kit (Kolloidales Gold) |
| 00100793 | 2021-07-12 | MedNet EC-REP GmbH | Jiangsu Bioperfectus Technologies Co., Ltd. | China | HN: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Selbsttest) |
| 00100252 | 2021-07-12 | Osmunda Medical Technology Service GmbH | GenSure Biotech Inc., | China | HN: GenSure COVID-19 Neutralizing Antibody Test (Latex) AP: Detection Card for COVID-19 Neutralizing Antibody |
| 00100251 | 2021-07-12 | Osmunda Medical Technology Service GmbH | GenSure Biotech Inc., | China | HN: GenSure COVID-19 Neutralizing Antibody Test (Fluorescence) AP: Detection Card for COVID-19 Neutralizing Antibody |
| 00100673 | 2021-07-09 | Medical Technology Promedt Consulting GmbH | General Biologicals Corporation | Taiwan | HN: GB COVID-19 Ag POCT |
| 00100492 | 2021-07-09 | Osmunda Medical Technology Service GmbH | INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD. | China | HN: 2019-nCoV Ag Test (Latex Chromatography Assay)_Saliva |
| 00099724 | 2021-07-09 | Osmunda Medical Technology Service GmbH | INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD. | China | HN: 2019-nCoV Ag Test (Latex Chromatography Assay)_Nasal |
| 00099658 | 2021-07-09 | Osmunda Medical Technology Service GmbH | Glallergen Co., Ltd. | China | HN: Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal gold immunochromatography) |
| 00099588 | 2021-07-09 | MedNet EC-REP GmbH | Beijing Zhongjian Antai Diagnostic Technology Co., Ltd. | China | AP: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) |
| 00100689 | 2021-07-08 | Medical Technology Promedt Consulting GmbH | Humasis Co.,Ltd | Korea, Rep. | HN: Humasis COVID-19 Ag Selbsttest (Atack Control) AP: Covid-19 AG Selbsttest |
| 00100683 | 2021-07-08 | ulti med Products (Deutschland) GmbH | HN: COVID-19 Antigen Speicheltest (Immunochromatographie) AP: 012G521-1 und 012G521-5 |
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| 00100675 | 2021-09-06 | KTR Europe GmbH | KOREA GENOME INFORMATION INSTITUTE | Korea, Rep. | HN: KGIC™ COVID-19 RT-LAMP Pro Kit PLUS AP: KGIC™ COVID-19 RT-LAMP Pro Kit PLUS |
| 00100540 | 2021-07-07 | gerbion GmbH & Co. KG | HN: virellaSARS-CoV-2 mutant 3 real time RT-PCR Kit AP: G01138 |
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| 00100093 | 2021-07-08 | Luxus Lebenswelt GmbH | Jiangsu Baozhilin Medical Technology Co., Ltd | China | HN: SARS-CoV-2 Antigen Rapid Test Kit AP: SARS-CoV-2 Antigen Rapid Test Kit |
| 00099930 | 2021-07-07 | MedNet EC-REP GmbH | Aikang Diagnostics Co., Ltd | China | HN: COVID-19 Neutralizing Antibody Test Kit (Competitive Method) |
| 00099548 | 2021-07-07 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: COVID-19 Antigen Rapid Test Cassette (Nasal Swab/Nasopharyngeal Swab) |
| 00099436 | 2021-07-07 | MedNet EC-REP GmbH | Chemclin Diagnostics Co., Ltd. | China | HN: 2019-nCoV Antibody (Light-initiated Chemiluminescence Immunoassay, LiCA) |
| 00098848 | 2021-07-07 | Shanghai International Holding Corporation GmbH (Europe) | Zhejiang Orient Gene Biotech Co., Ltd. | China | HN: Orient Gene AP: COVID-19 Antigen Control Kit |
| 00100063 | 2021-07-06 | Senova Gesellschaft für Biowissenschaft und Technik | HN: GreenLight SARS-CoV-2 antigen nasal rapid test | ||
| 00100271 | 2021-07-02 | DRG Instruments GmbH | HN: COVID-19 ACE2-RBD Neutralization Assay | ||
| 00100068 | 2021-07-02 | MIKROGEN GmbH | HN: ampliCube SARS-CoV-2 Variants | ||
| 00098782 | 2021-07-02 | S.B. Pharma GmbH | Cancer Rop Co., Ltd | Korea, Rep. | HN: Q-Sens® COVID-19 Detection Kit V2 AP: PCR Kit for Diagnosis of COVID-19 / |
| 00097844 | 2021-07-02 | S.B. Pharma GmbH | NDFOS Co., Ltd. | Korea, Rep. | HN: ND COVID-19 Ag Test AP: Immunoassay Kits / ND COVID-19 Ag Test |
| 00097843 | 2021-07-02 | S.B. Pharma GmbH | NDFOS Co., Ltd. | Korea, Rep. | HN: ND COVID-19 IgG/IgM Rapid Test AP: ND COVID-19 IgG / IgM |
| 00097842 | 2021-07-02 | S.B. Pharma GmbH | NDFOS Co., Ltd. | Korea, Rep. | HN: ND COVID-19 & Flu Combo Kit AP: PCR-Kit zur Diagnose von COVID-19 & Grippe |
| 00097841 | 2021-07-02 | S.B. Pharma GmbH | NDFOS Co., Ltd. | Korea, Rep. | HN: ND COVID-19 Detection Kit AP: PCR Kit for Diagnosis of COVID-19 |
| 00097687 | 2021-07-02 | S.B. Pharma GmbH | Cancer Rop Co., Ltd | Korea, Rep. | HN: Q-Sens® COVID 19 IgG/IgM Rapid Kit AP: Rapid Kit for Diagnosis of COVID-19 |
| 00097686 | 2021-07-02 | S.B. Pharma GmbH | Cancer Rop Co., Ltd | Korea, Rep. | HN: Q-Sens® 2019-nCoV Detection Kit AP: PCR Kit for Diagnosis of 2019-nCoV |
| 00100298 | 2021-06-30 | MedNet GmbH | ACON Biotech (Hangzhou) Co., Ltd. | China | HN: Flowflex AP: SARS-CoV-2 Neutralizing Antibody Rapid Test |
| 00099987 | 2021-06-30 | MedNet GmbH | Dewei Medical Equipment Co.,Ltd | China | HN: COVID-19 (2019-n-CoV) IgG/IgM Rapid Test Cassette |
| 00099023 | 2021-07-01 | MedNet EC-REP GmbH | Beijing Beier Bioengineering Co., Ltd | China | AP: Anti-SARS-CoV-2 Neutralizing Antibody Test Kit (ELISA) |
| 00100576 | 2021-06-29 | Abbott Rapid Diagnostics Jena GmbH | HN: Panbio COVID-19 Antigen Self-Test | ||
| 00100514 | 2021-06-29 | NanoRepro AG | HN: ZuhauseTEST Corona AP: SARS-CoV-2 Antigen Schnelltest |
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| 00100513 | 2021-06-29 | NanoRepro AG | HN: NanoRepro SARS-CoV-2 Antigen Schnelltest AP: SARS-CoV-2 Antigen Schnelltest |
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| 00100445 | 2021-06-29 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co.,Ltd. | China | HN: Novel Coronavirus(COVID-19) Neutralizing Antibody Rapid Test Device AP: Novel Coronavirus(COVID-19) Neutralizing Antibody Rapid Test Device |
| 00100313 | 2021-06-29 | BioeXsen GmbH | HN: BioeXsen SARS-CoV-2 Variant Plus | ||
| 00100290 | 2021-07-12 | MedNet GmbH | Hangzhou AllTest Biotech Co., Ltd. | China | HN: ALLTEST/ Beright/ JusChek/ Lambra/ SCREEN CHECK TEST/ Rapid Response COVID-19 Antigen Rapid Test (Oral Fluid) |
| 00099975 | 2021-06-29 | DRG Instruments GmbH | HN: SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/ Serum/ Plasma) | ||
| 00100091 | 2021-06-28 | Osmunda Medical Technology Service GmbH | Shanghai Chemtron Biotech. Co., Ltd. | China | HN: Chemtrue® COVID-19 (SARS-COV-2) Antigen Rapid Test Kit (Saliva) |
| 00100090 | 2021-06-28 | Osmunda Medical Technology Service GmbH | Shanghai Chemtron Biotech. Co., Ltd. | China | HN: Chemtrue® COVID-19 (SARS-COV-2) Antigen Rapid Test Kit (Nasal Swab) |
| 00100569 | 2021-06-25 | Pedima International GmbH | Pharma Tech Solutions, Inc. | Vereinigte Staaten von Amerika | HN: GenViro! Swift AP: Covid-19 digitaler Antigen Schnelltest |
| 00100212 | 2021-06-25 | NovaTec Immundiagnostica GmbH | HN: GSD NovaPrime Plus SARS-CoV-2 | ||
| 00100026 | 2021-06-25 | BAG Diagnostics GmbH | HN: SARS-CoV-2 Antigen Rapid Test | ||
| 00100017 | 2021-06-25 | NovaTec Immundiagnostica GmbH | HN: SARS-CoV-2 II ID | ||
| 00100016 | 2021-06-25 | NovaTec Immundiagnostica GmbH | HN: GSD NovaType II SARS-CoV-2 | ||
| 00099983 | 2021-06-25 | NovaTec Immundiagnostica GmbH | HN: GSD NovaPrime SARS-CoV-2 Direct | ||
| 00100547 | 2021-06-23 | Osmunda Medical Technology Service GmbH | Nantong Diagnos Biotechnology Co., Ltd. | China | HN: COVID-19 Antigen Test Kit (Colloidal Gold) - Anterior nasal |
| 00100543 | 2021-06-24 | DeRossi Investition & Entwicklung GmbH | Hangzhou DIAN Biotechnology Co., Ltd. | China | HN: SARS-CoV-2 Neutralizaion Antibody Detection Kit AP: SARS-CoV-2 Neutralizaion Antibody Detection Kit |
| 00100541 | 2021-06-24 | DeRossi Investition & Entwicklung GmbH | Hangzhou DIAN Biotechnology Co., Ltd. | China | HN: POC SARS-CoV-2 Nucleic Acid Detection Kit AP: SARS-CoV-2 Nucleic Acid Detection Kit |
| 00100493 | 2021-06-23 | JaviTech e.K. | PROTANBIO Inc. | Korea, Rep. | HN: PROTAN COVID-19 IgG Type2 |
| 00100372 | 2021-06-23 | Luxus Lebenswelt GmbH | ShenZhen Channel Biotechnology Co., Ltd. | China | HN: SARS-CoV-2 Neutralizing Antibody Rapid Test Kit (Colloidal Gold) AP: SARS-CoV-2 Neutralizing Antibody Rapid Test Kit (Colloidal Gold) |
| 00100272 | 2021-06-23 | KTR Europe GmbH | Quantamatrix Inc. | Korea, Rep. | HN: QPLEX COVID-19 Test AP: real-time RT-PCR Test |
| 00100220 | 2021-06-23 | Luxus Lebenswelt GmbH | Blue Cross Bio-Medical (Beijing) Co., Ltd. | China | HN: COVID-19 Antigen (nasal swab) Test kit AP: COVID-19 Antigen (nasal swab) Test kit |
| 00100378 | 2021-06-22 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: SARS-CoV-2 S-RBD IgG II (CLIA) |
| 00099794 | 2021-06-22 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | HN: Lifotronic AP: SARS-CoV-2 Nucleic Acid Detection Kit(Gene Mutation) |
| 00099792 | 2021-06-22 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | HN: Lifotronic AP: SARS-CoV-2 Nucleic Acid Detection Kit(Freeze-Dried) |
| 00100413 | 2021-06-21 | Aesku.Diagnostics GmbH & Co. KG | HN: AESKU.COLLECT DBS | ||
| 00100105 | 2021-05-12 | DeRossi Investition & Entwicklung GmbH | Nanjing Vazyme Medical Technology Co., Ltd | China | HN: SARS-CoV-2 RBD Protein IgG Detection Kit (Colloidal Gold-Based) AP: SARS-CoV-2 RBD Protein IgG Detection Kit |
| 00100104 | 2021-05-12 | DeRossi Investition & Entwicklung GmbH | Nanjing Vazyme Medical Technology Co., Ltd | China | HN: Anti-SARS-CoV- 2 Neutralizing Antibody ELISA Kit AP: Neutralizing Antibody Kit |
| 00099640 | 2021-05-12 | DeRossi Investition & Entwicklung GmbH | Hangzhou DIAN Biotechnology Co., Ltd. | China | HN: COVID-19 Antigen Test Cassette AP: COVID-19 Ag Test |
| 00100485 | 2021-06-16 | mdi Europa GmbH | Plexense, Inc. | Korea, Rep. | AP: Other Coronavirus Reagents |
| 00100470 | 2021-06-16 | Share Info GmbH | Wuhan Hygeianey Biological Technology Co., LTD | China | HN: Novel coronavirus (2019-nCoV) neutralizing antibody detection kit (ELISA) |
| 00100415 | 2021-06-16 | Share Info GmbH | Guangdong Hecin Scientific, Inc. | China | HN: 2019-nCoV S-RBD Neutralizing Antibody Test Kit(colloidal gold method) |
| 00100241 | 2021-06-16 | Luxus Lebenswelt GmbH | BeiJing Abace Biotechnology Co., Ltd. | China | HN: Novel Coronavirus (2019-nCoV) Antigen/Antibody Test Kit (Colloidal gold immunochromatography method) AP: Novel Coronavirus (2019-nCoV) Antigen/Antibody Test Kit (Colloidal gold immunochromatography method) |
| 00100476 | 2021-06-29 | mdi Europa GmbH | Excelsior-Biosystem Inc. | Taiwan | AP: Coronavirus RT & POC |
| 00100471 | 2021-06-15 | mdi Europa GmbH | Co-Diagnostics, Inc. | Vereinigte Staaten von Amerika | AP: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
| 00100370 | 2021-06-09 | Medical Device Safety Service GmbH | Aalto Scientific, Ltd. | Vereinigte Staaten von Amerika | HN: Linearity LQ Anti-SARS-CoV-2 S for Roche Systems |
| 00100316 | 2021-06-09 | Medical Device Safety Service GmbH | GuangZhou HEAS BioTech Co., Ltd. | China | HN: JeTest Direct FluA/FluB/2019-nCoV Detection Kit |
| 00100262 | 2021-06-10 | gerbion GmbH & Co. KG | HN: virellaSARS-CoV-2 mutant 2 real time RT-PCR Kit AP: G01136 |
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| 00100159 | 2021-06-10 | Luxus Lebenswelt GmbH | BeiJing Abace Biotechnology Co., Ltd. | China | HN: New Coronavirus (2019-nCoV) Neutralizing Antibody Test kit (ELISA) AP: New Coronavirus (2019-nCoV) Neutralizing Antibody Test kit (ELISA) |
| 00100147 | 2021-06-10 | Luxus Lebenswelt GmbH | Shenzhen Lvshiyuan Biotechnology Co., Ltd. | China | HN: SARS-CoV-2 Neutralizing Antibody Test Kit(Immunofluorescence Assay) AP: SARS-CoV-2 Neutralizing Antibody Test Kit(Immunofluorescence Assay) |
| 00100146 | 2021-06-10 | Luxus Lebenswelt GmbH | Shenzhen Lvshiyuan Biotechnology Co., Ltd. | China | HN: SARS-CoV-2 Neutralizing Antibody Rapid Test Kit(Colloidal Gold) AP: SARS-CoV-2 Neutralizing Antibody Rapid Test Kit(Colloidal Gold) |
| 00098314 | 2021-06-10 | Caretechion GmbH | Guangzhou Decheng Biotechnology Co., Ltd. | China | AP: 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography) |
| 00098211 | 2021-06-10 | Caretechion GmbH | Genobio Pharmaceutical Co., Ltd. | China | AP: COVID-19 Antigen Lateral Flow Assay |
| 00100341 | 2021-06-08 | Share Info GmbH | Guangdong Hecin Scientific, Inc. | China | HN: 2019-nCoV Saliva Antigen Rapid Test Kit |
| 00100295 | 2021-06-07 | ImmoGnost GmbH | HN: Immognost SARS-CoV-2 Antigen Schnelltest | ||
| 00100240 | 2021-06-07 | Medical Technology Promedt Consulting GmbH | Sugentech, Inc. | Korea, Rep. | HN: SGTi-Self COVID-19 IgM/IgG |
| 00099665 | 2021-06-07 | MedNet GmbH | Foshan Longsee Biotechnology Co., Ltd | China | AP: SARS-CoV-2 Antigen Rapid Test Kit |
| 00100270 | 2021-06-04 | nal von minden GmbH | HN: NADAL® COVID-19 S1-NAb Test | ||
| 00100261 | 2021-06-04 | nal von minden GmbH | HN: 243109N-20 dedicio® COVID-19 Ag pro Test AP: Covid-19 Ag Test |
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| 00099997 | 2021-06-04 | Dr. Fooke-Achterrath Laboratorien GmbH | HN: Anti-SARS-CoV-2-ELISA IgA AP: ELISA for the qualitative Determination of IgA-antibodies to SARS-CoV-2-antigen |
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| 00099996 | 2021-06-04 | Dr. Fooke-Achterrath Laboratorien GmbH | HN: Anti-SARS-CoV-2-ELISA IgG AP: ELISA for the qualitative Determination of IgG-antibodies to SARS-CoV-2-antigen |
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| 00099623 | 2021-06-02 | MedNet EC-REP GmbH | Bio-Lab Ltd. | Israel | AP: Viral Transfer Media DLB-90 |
| 00100304 | 2021-06-01 | JaviTech e.K. | Genesystem Co., Ltd. | Korea, Rep. | HN: SMARTCHEK® SARS-CoV-2/Flu/RSV Simultaneous Detection Kit |
| 00099971 | 2021-06-01 | MedNet EC-REP GmbH | GENCLONN Biotech (Hangzhou) Co., Ltd. | China | HN: SARS-CoV-2 Antigen Rapid Test |
| 00100243 | 2021-05-31 | Medical Device Safety Service GmbH | ACON Laboratories, Inc. | Vereinigte Staaten von Amerika | HN: Ritter® Easy Check SARS-CoV-2 Antigen Rapid Test (Self-Testing); Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing) |
| 00100211 | 2021-05-31 | Medical Device Safety Service GmbH | Epitope Diagnostics, Inc. | Vereinigte Staaten von Amerika | HN: EDI™ Quantitative SARS-CoV-2 Neutralizing Antibody ELISA Kit |
| 00100210 | 2021-05-31 | Medical Device Safety Service GmbH | Epitope Diagnostics, Inc. | Vereinigte Staaten von Amerika | HN: EDI™ Quantitative SARS-CoV-2 Spike Protein IgG ELISA Kit |
| 00100209 | 2021-05-31 | Medical Device Safety Service GmbH | iXensor Co., Ltd. | Taiwan | HN: PixoTest COVID-19 Ag Test Kit |
| 00100198 | 2021-05-31 | Medical Device Safety Service GmbH | GuangZhou HEAS BioTech Co., Ltd. | China | HN: JeTest Direct 2019-nCoV Detection Kit |
| 00100188 | 2021-05-31 | Medical Device Safety Service GmbH | Promega Corporation | Vereinigte Staaten von Amerika | HN: Lumit™ Dx SARS-CoV-2 Immunoassay |
| 00100184 | 2021-05-31 | Medical Device Safety Service GmbH | RAPID BIO, LLC | Russische Föderation | HN: Rapid Bio COVID-19 Ag |
| 00100143 | 2021-05-31 | HAIN LIFESCIENCE GmbH | HN: FluoroType® SARS-CoV-2 varID Q VER 1.0 | ||
| 00099864 | 2021-05-31 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Sejoy Electronics& Instruments Co., Ltd. | China | HN: Sejoy AP: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette |
| 00100256 | 2021-05-27 | Teda Laukoetter Technologie GmbH | HN: ANBIO CORONA ANTIGEN NASENTUPFER AP: Antigen Schnelltest zur Detektion von SARS-CoV 2 Viren |
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| 00099991 | 2021-05-27 | KTR Europe GmbH | COSMAXPHARMA | Korea, Rep. | HN: COVID-19 Antigen Rapid Test 1) NOW Detect COVID-19 Antigen Rapid Test 2) PAZBIO Novel Corona Virus(2021-nCoV)-Detection Kit AP: IVD-Reagenz zum Nachweis infektiöser Krankheitserreger SARS-CoV-2 |
| 00099589 | 2021-04-01 | KTR Europe GmbH | SGENEBIO Co., Ltd. | Korea, Rep. | HN: SARS-CoV-2 Easy Kit (Real-time PCR) RC12012A, RC12012B AP: Real-time PCR Kit |
| 00099579 | 2021-04-01 | KTR Europe GmbH | Inogenix Inc. | Korea, Rep. | HN: INO SARS-CoV-2 Detection Kit - COV5R100 AP: Diagnosekit für SARS CoV 2 |
| 00099122 | 2021-05-26 | Caretechion GmbH | InTelos Inc. | Korea, Rep. | HN: MAUVETM (TM)COVID-19 Ag Test AP: Rapid Diagnostic Test |
| 00100232 | 2021-05-25 | MP Biomedicals Germany GmbH | HN: Rapid SARS-CoV-2 Antigen Test Card AP: SARS-CoV-2 Antigen Schnelltest |
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| 00100168 | 2021-07-19 | Intermundien-Lemon Europe GmbH | WIZCHEM CO., LTD. | Korea, Rep. | HN: COVICHEK™ COVID-19 Ag Kit |
| 00100145 | 2021-06-16 | myPOLS Biotec GmbH | HN: Volcano3G® Direct COVID-19 Kit | ||
| 00100002 | 2021-05-25 | PureMDR GmbH | Fidens Care LLC | Vereinigte Staaten von Amerika | HN: Fidens Care SARS-CoV-2 Rapid Antigen Test AP: SARS-CoV-2 Rapid Antigen Test |
| 00100095 | 2021-05-21 | Luxus Lebenswelt GmbH | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. | China | HN: DEEPBLUE AP: COVID-19 (SARS-CoV-2) Neutralizing Antibody (Double Antigen Sandwich) Test Kit (Colloidal Gold) |
| 00099939 | 2021-05-21 | JaviTech e.K. | ImmuneMed, Inc. | Korea, Rep. | HN: ImmuneMed COVID-19 Ag RAPID AP: Rapid Diagnostic Kits for infectious Diseases |
| 00099681 | 2021-05-21 | JaviTech e.K. | Genes Laboratories | Korea, Rep. | HN: NEXdia™ COVID-19 & Influenza A/B Detection Kit AP: Novel Coronavirus & Influenza A/B detection kit |
| 00100037 | 2021-05-19 | Sysmex Europe GmbH | Sysmex Corporation | Japan | HN: HISCL SARS-CoV-2 Ag Control |
| 00100036 | 2021-05-19 | Sysmex Europe GmbH | Sysmex Corporation | Japan | HN: HISCL SARS-CoV-2 Ag Calibrator |
| 00100035 | 2021-05-19 | Sysmex Europe GmbH | Sysmex Corporation | Japan | HN: HISCL SARS-CoV-2 Ag Assay Kit |
| 00100182 | 2021-05-17 | Medical Technology Promedt Consulting GmbH | OPTOLANE Technologies, Inc. | Korea, Rep. | HN: Kaira™ COVID-19/Flu Detection kit |
| 00100175 | 2021-05-17 | Medical Technology Promedt Consulting GmbH | Atlas Link Technology Co., Ltd. | China | HN: NOVA Test® SARS-CoV-2 Antigen Schnelltestkit (Kolloidale Gold Immunchromatographie) AP: SARS-CoV-2 Antigen Schnelltestkit zur Eigenanwendung |
| 00100167 | 2021-05-17 | Medical Technology Promedt Consulting GmbH | SpeeDx Pty Ltd. | Australien | HN: PlexPCR® SARS-CoV-2 |
| 00099802 | 2021-05-14 | Bio-Gram Diagnostics Germany | Guangdong Wesail Biotech Co., Ltd. | China | HN: Covid-19 AG Test Kit AP: Covid-19 Antigen Schnelltest Kit |
| 00099995 | 2021-05-10 | Dräger Safety AG & Co. KGaA | HN: Dräger Antigen Test SARS-CoV-2 | ||
| 00099391 | 2021-05-10 | Shanghai International Holding Corporation GmbH (Europe) | Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. | China | HN: Konsung AP: COVID-19 Neutralizing Antibody Rapid Test Kit (Colloidal Gold) |
| 00098933 | 2021-05-10 | Luxus Lebenswelt GmbH | Shanghai Bionaire Biotech Co., Ltd. | China | HN: Novel Coronavirus (COVID-19) Antigen Test (Colloidal Gold) AP: Novel Coronavirus (COVID-19) Antigen Test (Colloidal Gold) |
| 00100097 | 2021-05-12 | Brawa GmbH | HN: Testsealabs® COVID-19 (SARS-CoV-2) Antigen Schnelltest | ||
| 00098248 | 2021-05-07 | MedPath GmbH | Guangdong Longsee Biomedical Co., Ltd. | China | HN: 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) |
| 00099889 | 2021-05-06 | MedPath GmbH | Shanghai Bionaire Biotech Co., Ltd. | China | HN: Novel Coronavirus (COVID-19) Neutralizing Antibodies Test (Colloidal Gold) |
| 00098824 | 2021-05-06 | Icon Medlab GmbH | Beijing Lepu Medical Technology Co., Ltd. | China | HN: 2019-nCoV Antigen Rapid Test Kit AP: 2019-nCoV Antigen Rapid Test Kit |
| 00100046 | 2021-05-03 | Medical Technology Promedt Consulting GmbH | Green Cross Medical Science Corporation | Korea, Rep. | HN: GENEDIA W COVID-19 Ag External Control Swab |
| 00100023 | 2021-07-14 | MedPath GmbH | Guangdong Longsee Biomedical Co., Ltd. | China | HN: 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) |
| 00099869 | 2021-05-03 | BioeXsen GmbH | HN: BioeXsen SARS-CoV-2 Variant Plus S2R | ||
| 00099647 | 2021-05-03 | MEDsan GmbH | HN: MEDsan® SARS-CoV-2-Vaccine Multiplex Antibody Rapid Test | ||
| 00098947 | 2021-05-03 | BioeXsen GmbH | HN: BioeXsen SARS-CoV-2 N501Y Mutation Detection Kit | ||
| 00098944 | 2021-05-03 | BioeXsen GmbH | HN: BioeXsen SARS-CoV-2 Double Gene RT PCR | ||
| 00098836 | 2021-05-03 | MEDsan GmbH | HN: MEDsan SARS-CoV-2 Ag Duo | ||
| 00100022 | 2021-04-30 | Medical Technology Promedt Consulting GmbH | ADT Biotech Sdh. Bhd. | Malaysia | HN: LyteStar ™ 2019-nCoV RT-PCR Kit 2.0 |
| 00099965 | 2021-04-28 | NovaTec Immundiagnostica GmbH | Hangzhou AllTest Biotech Co., Ltd. | China | HN: GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal swab) |
| 00099964 | 2021-04-28 | NovaTec Immundiagnostica GmbH | Hangzhou AllTest Biotech Co., Ltd. | China | HN: GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP swab) |
| 00099873 | 2021-04-28 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Sejoy Electronics& Instruments Co., Ltd. | China | HN: Sejoy AP: SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette |
| 00099467 | 2021-04-29 | Luxus Lebenswelt GmbH | Wuhan CIC Hanjia Technology Co. , Ltd. | China | HN: 2019-nCoV Antigen Rapid Test Kit AP: 2019-nCoV Antigen Rapid Test Kit |
| 00098988 | 2021-04-29 | AXIOM Gesellschaft für Diagnostica und Biochemica mbH | HN: COVID-19 Antigen Speichel Rapid Test Card | ||
| 00098913 | 2021-04-29 | Luxus Lebenswelt GmbH | Wuhan CIC Hanjia Technology Co. , Ltd. | China | HN: 2019-nCoV IgM/IgG Rapid Test AP: 2019-nCoV IgM/IgG Rapid Test |
| 00098912 | 2021-04-29 | Luxus Lebenswelt GmbH | Wuhan CIC Hanjia Technology Co. , Ltd. | China | HN: 2019-nCoV/FIU A/B Antigen Combo Rapid Test AP: 2019-nCoV/FIU A/B Antigen Combo Rapid Test |
| 00098740 | 2021-04-29 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co., Ltd. | China | HN: Novel Coronavirus (SARS-Cov-2) Neutralizing Antibody Assay Reagent Kit (CMIA) AP: Novel Coronavirus (SARS-Cov-2) Neutralizing Antibody Assay Reagent Kit (CMIA) |
| 00098739 | 2021-04-29 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co., Ltd. | China | HN: Novel coronavirus (SARS-Cov-2) neutralizing antibody Rapid Test Device AP: Novel coronavirus (SARS-Cov-2) neutralizing antibody Rapid Test Device |
| 00097153 | 2021-04-29 | Immundiagnostik AG | HN: IDK® anti-SARS-CoV-2 IgM ELISA | ||
| 00099994 | 2021-09-17 | Medical Technology Promedt Consulting GmbH | Sugentech, Inc. | Korea, Rep. | HN: SGTi-flex COVID-19 Ag AP: Covid-19 Ag Test zur Eigenanwendung |
| 00099900 | 2021-04-27 | Servoprax GmbH | HN: Cleartest Corona IgG-Spike AP: Cleartest Corona |
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| 00099649 | 2021-04-27 | MedNet GmbH | ACON Biotech (Hangzhou) Co., Ltd. | China | HN: Flowflex AP: SARS-CoV-2 Antigen Rapid Test Strip |
| 00099621 | 2021-04-27 | LEBENKO | Won Medical Corp. | Korea, Rep. | HN: WM COV AB 25T AP: Wonmed Covid-19 IgM/IgG |
| 00099094 | 2021-04-27 | MedNet GmbH | Shenzhen Kisshealth Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 Total Antibodies & Neutralizing Antibodies Test Kit (Colloidal Gold) |
| 00099671 | 2021-04-26 | EUROIMMUN Medizinische Labordiagnostika AG | AP: SARS-CoV-2-NeutraLISA | ||
| 00099495 | 2021-04-26 | NIC GmbH | Safecare Biotech (Hangzhou) Co., Ltd. | China | HN: COVID19 Neutralizing Antibody Rapid Test Kit (Whole blood/Serum/Plasma) |
| 00099348 | 2021-04-26 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Enzyme-linked Immunosorbent Assay)) |
| 00099976 | 2021-04-23 | Günter Keul GmbH | HN: SARS-CoV-2 Antigentest Kit AP: COVID-19 Antigen-Schnelltestkassette |
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| 00099898 | 2021-04-23 | MedNet EC-REP GmbH | Aikang Diagnostics Co., Ltd | China | HN: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) |
| 00099748 | 2021-04-23 | Pierenkemper GmbH | HN: COVIDENT COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid test | ||
| 00097463 | 2021-04-23 | Share Info Consultant Service LLC Repräsentanzbüro | SICHUAN MASS SPECTROMETRY BIOTECHNOLOGY CO., LTD | China | HN: Novel Coronavirus (2019-nCov) Antigen Detection Kit (Latex Chromatography) |
| 00098911 | 2021-04-21 | Luxus Lebenswelt GmbH | ShenZhen Channel Biotechnology Co., Ltd. | China | HN: Rapid SARS-CoV-2 antigen detection kit (Latex) AP: Rapid SARS-CoV-2 antigen detection kit (Latex) |
| 00098871 | 2021-04-21 | Luxus Lebenswelt GmbH | ShenZhen Channel Biotechnology Co., Ltd. | China | HN: Rapid SARS-CoV-2 antigen detection kit (Colloidal Gold) AP: Rapid SARS-CoV-2 antigen detection kit (Colloidal Gold) |
| 00096123 | 2021-04-21 | Luxus Lebenswelt GmbH | Suzhou Yingze Bio-Med Sci & Tech Co., Ltd. | China | HN: SARS-CoV-2 Nucleic Acid Detection Kit (RT-PCR) AP: SARS-CoV-2 Nucleic Acid Detection Kit (RT-PCR) |
| 00099882 | 2021-04-20 | NanoRepro AG | HN: NanoRepro COVID-19 Antigen Rapid Test (Viromed) /NanoRepro COVID-19 Antigen Schnelltest(Viromed) AP: RAPID DIAGNOSTIC TEST |
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| 00099667 | 2021-04-20 | Medical Technology Promedt Consulting GmbH | ADtech Co, Ltd. | Korea, Rep. | HN: ADTech COVID-19 Ag RAPID KIT; GBT COVID-19 Ag RAPID KIT AP: Rapid Test Kit for COVID-19 Ag |
| 00099883 | 2021-08-11 | Medical Device Safety Service GmbH | Quidel Corporation | Vereinigte Staaten von Amerika | HN: QuickVue® SARS Antigen Test; Sofia® 2 SARS-CoV-2 Antibody IgG FIA |
| 00099773 | 2021-04-19 | Servoprax GmbH | HN: Cleartest Corona Nasal AP: Cleartest Corona |
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| 00099626 | 2021-04-19 | MedNet EC-REP GmbH | Aikang Diagnostics Co., Ltd | China | HN: COVID-19 Neutralizing Antibody Test Kit (ELISA) |
| 00099591 | 2021-04-19 | MedNet EC-REP GmbH | Qingdao Hightop Biotech Co. Ltd. | China | AP: SARS-CoV-2 Antibody/Neutralizing Antibody Combo Rapid Test |
| 00099576 | 2021-04-19 | Shanghai International Holding Corporation GmbH (Europe) | Nantong Egens Biotechnology Co., Ltd | China | HN: Egens AP: SARS-CoV-2 Neutralizing Antibody Rapid Test Kit |
| 00099575 | 2021-04-19 | Shanghai International Holding Corporation GmbH (Europe) | Nantong Egens Biotechnology Co.,Ltd | China | HN: Egens AP: SARS-CoV-2 Multiplex Antibody Rapid Test Kit |
| 00099363 | 2021-04-19 | MedNet EC-REP GmbH | Aikang Diagnostics Co., Ltd | China | HN: SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold) |
| 00097774 | 2021-04-19 | Shanghai International Holding Corporation GmbH (Europe) | Nantong Egens Biotechnology Co.,Ltd | China | HN: Egens AP: SARS-CoV-2 Antigen Rapid Test |
| 00099881 | 2021-04-16 | Icon Medlab GmbH | HN: SARS-CoV-2 Antigen Rapid Test Kit | ||
| 00099411 | 2021-04-16 | MSP bodmann GmbH | HN: MSP SARS-CoV-2 Antigen-Schnelltest AP: 15 70 90 |
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| 00099765 | 2021-04-14 | MP Biomedicals Germany GmbH | HN: MP SARS-CoV-2 Antigen Rapid Test | ||
| 00099749 | 2021-04-13 | jtc-diagnostics | Pishtaz Teb | Iran, Islam. Rep. | HN: SARS CoV-2 Antigen Rapid Test AP: Rapid CoV-2 Antigen Test |
| 00099739 | 2021-08-09 | QIAGEN GmbH | HN: artus AP: artus SARS-CoV-2 Prep&Amp UM Kit |
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| 00099734 | 2021-04-13 | Devidia GmbH | HN: DEDIATEST Frontnasal 2019-nCoV-Antigen Schnelltest AP: Chromatographischer Immunoassay für den qualitativen Nachweis von SARS-CoV-2 Antigen (Nukleocapsid) in einer Abstrichprobe aus der vorderen Nase. |
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| 00099803 | 2021-04-12 | Bio-Gram Diagnostics Germany | HN: COVID-19 Ag Test Kit AP: Covid-19 Antigen Schnelltest für Laien |
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| 00099785 | 2021-04-12 | MedNet EC-REP GmbH | Qingdao Hightop Biotech Co. Ltd. | China | HN: HIGHTOP SARS-CoV-2 (COVID-19) Antigen Rapid Test |
| 00099532 | 2021-04-12 | Luxus Lebenswelt GmbH | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. | China | HN: COVID-19 (SARS-CoV-2) Neutralizing Antibody IgG Test Kit (Colloidal Gold) AP: COVID-19 (SARS-CoV-2) Neutralizing Antibody IgG Test Kit (Colloidal Gold) |
| 00099469 | 2021-04-12 | Kröner Medizintechnik GmbH | Diasia Biomedical Technology Co. Ltd. | China | HN: SARS-CoV-2 Antigen Rapid Test Kit AP: Schnelltest, SARS-CoV-2 |
| 00099775 | 2021-05-31 | MedNet GmbH | ACON Biotech (Hangzhou) Co., Ltd. | China | HN: SARS-CoV-2 Antigen Rapid Test (Self-Testing) |
| 00097920 | 2021-04-09 | Günter Keul GmbH | HN: Keul-o-test Covid-19 Antigen Speichel Schnelltestkassette AP: COVID-19 Antigen-Schnelltestkassette |
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| 00099492 | 2021-04-07 | MedNet EC-REP GmbH | Getein Biotech, Inc. | China | HN: SARS-CoV-2 Neutralizing Antibody Fast Test KIt (Immunofluorescence Assay) |
| 00099487 | 2021-04-07 | MedNet EC-REP GmbH | Getein Biotech, Inc. | China | HN: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) |
| 00099435 | 2021-04-08 | DiaSys Diagnostic Systems GmbH | HN: TruLab SARS-CoV-2 | ||
| 00099434 | 2021-04-08 | DiaSys Diagnostic Systems GmbH | HN: TruCal SARS-CoV-2 | ||
| 00099433 | 2021-04-08 | DiaSys Diagnostic Systems GmbH | HN: SARS-CoV-2 UTAB Sample Dilution Matrix | ||
| 00099431 | 2021-04-08 | DiaSys Diagnostic Systems GmbH | HN: SARS-CoV-2 UTAB FS | ||
| 00099722 | 2021-04-06 | CTG China Trading GmbH | Beijing Hotgen Biotech Co., Ltd | China | HN: Coronavirus (2019-nCoV)-Antigentest AP: Coronavirus (2019-nCoV)-Antigentest |
| 00099721 | 2021-04-06 | Shanghai International Holding Corporation GmbH (Europe) | Healgen Scientific Limited Liability Company | Vereinigte Staaten von Amerika | HN: Healgen AP: CLINITEST Rapid COVID-19 Self-Test |
| 00099718 | 2021-04-06 | CTG China Trading GmbH | Hangzhou Clongene Biotech Co., Ltd. | China | HN: COVID-19 Antigen Rapid Test AP: COVID-19 Antigen Rapid Test |
| 00099717 | 2021-04-06 | CTG China Trading GmbH | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind COVID-19 Antigen Schnelltest AP: Watmind COVID-19 Antigen Schnelltest |
| 00099702 | 2021-04-06 | nal von minden GmbH | HN: NADAL COVID-19 Ag Test | ||
| 00099342 | 2021-04-06 | Bio-Gram Diagnostics Germany | Guangdong Wesail Biotech Co., Ltd. | China | HN: COVID-19 NAb AP: Covid-19 neutralizing Antibod Test Kit |
| 00098675 | 2021-04-06 | Shanghai International Holding Corporation GmbH (Europe) | Changsha Sinocare Inc. | China | HN: Sinocare AP: SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) |
| 00097723 | 2021-04-06 | Shanghai International Holding Corporation GmbH (Europe) | Nantong Egens Biotechnology Co.,Ltd. | China | HN: Egens AP: Antigens Multiplex (FluA/FluB/SARS-COV-2) Rapid Test Kit |
| 00099700 | 2021-04-04 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clongene AP: COVID-19 Antigen Rapid Test |
| 00099699 | 2021-04-04 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 Antigen Schnelltest |
| 00099687 | 2021-04-01 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | HN: Coronavirus (2019-nCoV)-Antigentest - Speichel |
| 00099672 | 2021-03-31 | Medical Technology Promedt Consulting GmbH | AnteoTech Ltd. | Australien | HN: EuGeni AX-2X-S (Model AX-P006513) |
| 00099669 | 2021-03-31 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | HN: Coronavirus (2019-nCoV)-Antigentest |
| 00099659 | 2021-04-01 | Medical Device Safety Service GmbH | CTK Biotech, Inc. | Vereinigte Staaten von Amerika | HN: Aridia SARS-CoV-2 & Influenza A/B Real-Time PCR Test |
| 00099651 | 2021-03-31 | Medical Technology Promedt Consulting GmbH | THERAGEN GENOMECARE | Korea, Rep. | HN: THERAGEN COVID-19 ASSAY AP: Echtzeit-RT-PCR-Test für den qualitativen Nachweis von Nukleinsäure von SARS-CoV-2 |
| 00099499 | 2021-04-01 | Medical Device Safety Service GmbH | CENTRILLION TECHNOLOGIES TAIWAN CO., LTD. | Taiwan | HN: Virus Hunter™ SARS-CoV-2 Assay |
| 00099366 | 2021-04-01 | KTR Europe GmbH | KOREA GENOME INFORMATION INSTITUTE | Korea, Rep. | HN: KGIC COVID-19 IgM/IgG Kit AP: COVID-19 IgM/IgG Kit |
| 00098784 | 2021-04-01 | MedNet EC-REP GmbH | Qingdao Hightop Biotech Co. Ltd. | China | AP: SARS-CoV-2 Antigen Saliva Rapid Test |
| 00099661 | 2021-03-30 | Haemato Pharm GmbH | HN: Wondfo 2019-nCoV Antigen Test (Lateral-Flow-Methode) Selbsttest AP: Antigenschnelltest zur Eigenanwendung durch Laien |
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| 00098787 | 2021-03-30 | Caretechion GmbH | MEIZHOU CORNLEY® HI-TECH CO.,LTD | China | AP: COVID-19 (SARS-CoV-2) Antigen Test Kit |
| 00099635 | 2021-03-29 | Medical Technology Promedt Consulting GmbH | AnteoTech Ltd. | Australien | HN: EuGeni SARS-CoV-2 Ag RDT |
| 00099438 | 2021-03-29 | MedNet EC-REP GmbH | Chemclin Diagnostics Co., Ltd. | China | HN: 2019-nCoV IgG Antibody (Light-initiated Chemiluminescence Immunoassay, LiCA) |
| 00098992 | 2021-04-08 | MedNet EC-REP GmbH | Labnovation Technologies, Inc. | China | HN: SARS-CoV-2 Antigen Saliva Rapid Test Kit (Immunochromatography) |
| 00099567 | 2021-03-26 | Medical Device Safety Service GmbH | Diazyme Laboratories, Inc | Vereinigte Staaten von Amerika | HN: Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit |
| 00099458 | 2021-09-23 | Medical Device Safety Service GmbH | Daan Gene Co., Ltd. | China | HN: Detection Kit for SARS-CoV-2 UK and South African Variants (PCR-Fluorescence); Detection Kit for 2019-nCoV (PCR-Fluorescence); 2019-nCoV Delta Variant Detection Kit (PCR-Fluorescence Probing); Detection Kit for 2019-nCoV (E/N/RDRP Gene) |
| 00099630 | 2021-03-25 | OFM GmbH | HN: Sensitivo COVID-19 Antigen Test AP: Antigen Selbsttest |
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| 00099629 | 2021-03-25 | OFM GmbH | HN: Deni COVID-19 Antigen Test AP: Antigen Selbsttest |
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| 00099602 | 2021-03-25 | DRG Instruments GmbH | HN: COVID-19 Antigen Rapid Test (Nasal Swab) | ||
| 00098312 | 2021-03-24 | Shanghai International Holding Corporation GmbH (Europe) | Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. | China | HN: Konsung AP: COVID-19/Influenza A&B Antigen Rapid Test Kit (Colloidal Gold) |
| 00099166 | 2021-03-23 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | HN: Lifotronic AP: SARS-CoV-2 Neutralization Ab (GICA) |
| 00099561 | 2021-03-22 | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clungene AP: COVID-19 Antigen Rapid Test |
|
| 00099539 | 2021-03-22 | AB Diagnostic Systems GmbH | RPC Diagnostic Systems Ltd. | Russische Föderation | HN: DS-EIA-ANTI-SARS-CoV-2-G (S) AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION |
| 00099537 | 2021-03-22 | AB Diagnostic Systems GmbH | RPC Diagnostic Systems Ltd. | Russische Föderation | HN: DS-EIA-ANTI-SARS-CoV-2-SPECTRUM AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION |
| 00099528 | 2021-03-22 | ScheBo Biotech AG | HN: ScheBo SARS CoV-2 Quick Antigen (Colloidal Gold Method) | ||
| 00099402 | 2021-03-22 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co.,Ltd. | China | HN: Mindray AP: SARS-CoV-2 Total Antibody Control (H) |
| 00099401 | 2021-04-08 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co.,Ltd. | China | HN: Mindray AP: SARS-CoV-2 Total Antibody Control (L) |
| 00099400 | 2021-03-22 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co.,Ltd. | China | HN: Mindray AP: Severe Acute Respiratory Syndrome Coronavirus 2 Total Antibody (CLIA) |
| 00099397 | 2021-03-22 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 Neutralizing Antibody Test kit (Colloidal Gold) |
| 00099396 | 2021-03-22 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 Neutralizing Antibody Test kit (Immuno-fluorescence) |
| 00099365 | 2021-03-22 | NanoRepro AG | HN: NANOREPRO SARS-CoV-2 Saliva Antigen Test AP: SARS-CoV-2 Antigen Schnelltest |
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| 00099116 | 2021-03-22 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (COMBO) |
| 00098306 | 2021-03-22 | altona Diagnostics GmbH | HN: AltoStar SARS-CoV-2 RT-PCR Kit 1.5 | ||
| 00099551 | 2021-06-10 | Medical Technology Promedt Consulting GmbH | SD Biosensor, Inc. | Korea, Rep. | HN: SARS-CoV-2 Antigen Self Test Nasal |
| 00099540 | 2021-03-19 | Medical Technology Promedt Consulting GmbH | OPTI Medical Systems, Inc. | Vereinigte Staaten von Amerika | HN: OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test |
| 00099440 | 2021-03-19 | MedNet EC-REP GmbH | Chemclin Diagnostics Co., Ltd. | China | HN: 2019-nCoV Neutralizing Antibody (Light-initiated Chemiluminescence Immunoassay, LiCA) |
| 00099439 | 2021-03-19 | MedNet EC-REP GmbH | Chemclin Diagnostics Co., Ltd. | China | HN: 2019-nCoV IgM Antibody (Light-initiated Chemiluminescence Immunoassay, LiCA) |
| 00099360 | 2021-03-19 | NovaTec Immundiagnostica GmbH | HN: GSD NovaLisa AP: SARS-CoV-2 quantitative IgG |
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| 00098972 | 2021-03-19 | MedNet EC-REP GmbH | Qingdao Hightop Biotech Co. Ltd. | China | AP: SARS-CoV-2/Flu A+B/AdV/RSV Antigen Rapid Test |
| 00098544 | 2021-03-19 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Competition Colloidal Gold Assay) |
| 00099538 | 2021-03-18 | NanoRepro AG | HN: NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed) /NanoRepro SARS-CoV-2 Antigen Rapid Test (Viromed) AP: SARS-CoV-2 Antigen Schnelltest |
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| 00099533 | 2021-03-18 | WQS Management Consultants GmbH | Bejing Lepu Medical Technology Co. LTD | China | HN: SARS-CoV-2 Antigen Rapid Test Kit AP: immunchromatographischer Test |
| 00099521 | 2021-03-17 | gerbion GmbH & Co. KG | HN: respiraSC2-FluA/B seqc real time RT-PCR Kit AP: G01130 |
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| 00098541 | 2021-03-17 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Up-converting Phosphor Immunochromatographic Technology) |
| 00098330 | 2021-03-17 | Shanghai International Holding Corporation GmbH (Europe) | Maccura Biotechnology Co., Ltd. | China | HN: Maccura AP: SARS-CoV-2 Antigen (CLIA) |
| 00098329 | 2021-03-17 | Shanghai International Holding Corporation GmbH (Europe) | Maccura Biotechnology Co., Ltd. | China | HN: Maccura AP: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method |
| 00098297 | 2021-03-18 | Protzek Gesellschaft für biomedizinische Technik mbH | HN: EP COVID-19 Antigen-Test | ||
| 00099287 | 2021-03-16 | mdi Europa GmbH | Firstep Bioresearch, Inc. | Taiwan | AP: Coronavirus - RT & POC |
| 00099119 | 2021-03-16 | EUROIMMUN Medizinische Labordiagnostika AG | AP: EUROLINE Anti-SARS-CoV-2-Profil | ||
| 00098979 | 2021-03-15 | Luxus Lebenswelt GmbH | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. | China | HN: COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold ) AP: COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold ) |
| 00098914 | 2021-03-15 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co.,Ltd. | China | HN: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) AP: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) |
| 00098769 | 2021-08-16 | TIB Molbiol Syntheselabor GmbH | HN: LightMix SARS-CoV-2 E+N UBC AP: 40-0770-96 |
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| 00097849 | 2021-03-15 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: Quadruplex Real-Time PCR Diagnostic Kit for Rapid Detection of 2019-nCoV and Influenza Viruses A/B AP: Quadruplex Real-Time PCR Diagnostic Kit for Rapid Detection of 2019-nCoV and Influenza Viruses A/B |
| 00097193 | 2021-03-15 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: Duplex Real-Time PCR Kit for Rapid Detection of 2019-nCoV ORF1ab/N gene AP: Duplex Real-Time PCR Kit for Rapid Detection of 2019-nCoV ORF1ab/N gene |
| 00099448 | 2021-03-12 | Medical Technology Promedt Consulting GmbH | Unima Diagnosticos de Mexico S de RL de CV | Mexiko | HN: Xplora™ AP: Smartphone-Anwendung zur Auswertung von Ergebnissen von Rapid SARS-CoV-2 Antigen Test in Speichelproben mit dem Produkt Find™ |
| 00099432 | 2021-03-12 | Medical Technology Promedt Consulting GmbH | SLSBio Co. Ltd. | Korea, Rep. | HN: SsmarTest COVID-19 Ag Detection Kit (Model huCOVID19-04) |
| 00099349 | 2021-03-12 | gerbion GmbH & Co. KG | HN: virellaSARS-CoV-2 mutant real time RT-PCR Kit AP: G01132 |
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| 00099347 | 2021-03-12 | gerbion GmbH & Co. KG | HN: respiraScreen 2 LC real time RT-PCR Kit AP: G01134 |
||
| 00099346 | 2021-03-12 | gerbion GmbH & Co. KG | HN: respiraSC2 multi gene real time RT-PCR Kit AP: G01133 |
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| 00099345 | 2021-03-12 | gerbion GmbH & Co. KG | HN: respiraScreen 2 real time RT-PCR Kit AP: G01131 |
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| 00099070 | 2021-03-12 | MedNet GmbH | Salignostics Ltd. | Israel | HN: SaliCOV Saliva COVID-19 Rapid Test Kit |
| 00099335 | 2021-03-10 | jtc-diagnostics | ADDBIOMEDITEK CO. | Korea, Rep. | HN: Add Medi SARS-CoV-2 RT-qPCR Kit AP: RT-PCR Kit |
| 00099420 | 2021-03-09 | Textil ONE GmbH | Beijing Hotgen Biotech Co., Ltd. | China | HN: Coronavirus (2019-nCoV)-Antigentest AP: Coronavirus (2019-nCoV)-Antigentest (Colloidal Gold) zur Eigenanwendung (Laientest) |
| 00099355 | 2021-03-09 | B.R.A.H.M.S GmbH | Microgenics Corporation, part of Thermo Fisher Scientific | Vereinigte Staaten von Amerika | HN: ASAPath COVID-19 Antigen Rapid Test Kit AP: ASAPath COVID-19 Antigen Rapid Test Kit |
| 00099356 | 2021-08-27 | Immundiagnostik AG | HN: MutaPLex® CoV-2 MUT, MutaPLex® CoV-2 MUT 2, MutaPLex® CoV-2 MUT 3 | ||
| 00099251 | 2021-03-08 | Immundiagnostik AG | HN: IDK anti SARS-CoV-2 lgG | ||
| 00098637 | 2021-03-05 | MedNet EC-REP GmbH | Cell ID Pte Ltd. | Singapur | HN: Quiz SARS-CoV-2-NAT System AP: Replacement Kit: PCR Biochip |
| 00098635 | 2021-03-05 | MedNet EC-REP GmbH | Cell ID Pte Ltd. | Singapur | HN: Quiz SARS-CoV-2-NAT System AP: App |
| 00099337 | 2021-03-02 | Medical Technology Promedt Consulting GmbH | Atlas Link Technology Co., Ltd. | China | HN: FASPIT™ (SARS-CoV-2 Antigen Saliva Test (Colloidal Gold Immunochromato-graphy)) |
| 00098777 | 2021-03-02 | ImmoGnost GmbH | HN: Racordiax COVID-19 Antibody Rapid Test | ||
| 00099129 | 2021-03-01 | KTR Europe GmbH | KOREA GENOME INFORMATION INSTITUTE | Korea, Rep. | HN: KGIC-Nano™ COVID-19 RT-LAMP Pro Kit AP: COVID-19 RT-LAMP Pro Kit |
| 00099015 | 2021-02-26 | MedNet EC-REP GmbH | Qingdao Hightop Biotech Co. Ltd. | China | AP: SARS-CoV-2 Neutralizing Antibody Test |
| 00099014 | 2021-02-26 | MedNet EC-REP GmbH | Qingdao Hightop Biotech Co. Ltd. | China | AP: SARS-CoV-2 Neutralizing Antibody Rapid Test |
| 00099305 | 2021-02-25 | Medical Technology Promedt Consulting GmbH | ProteomeTech Inc. | Korea, Rep. | HN: Product name: GENEdania, Model name: GENEdania SARS-CoV-2/FluA/FluB Fast qRT-PCR |
| 00099221 | 2021-02-25 | Medical Technology Promedt Consulting GmbH | Unima Diagnosticos de Mexico S de RL de CV | Mexiko | HN: Find SARS-CoV-2 AP: Rapid SARS-CoV-2 antigen test in Saliva |
| 00098948 | 2021-06-28 | SelfDiagnostics Deutschland GmbH | HN: SelfDiagnostics Deutschland GmbH AP: SARS-CoV-2 Antigen Rapid Test Kit (Nasal/Saliva) |
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| 00097524 | 2021-02-25 | MEDsan GmbH | HN: MEDsan® Multiplex (SC2 & Flu A/B) Rapid Test | ||
| 00097476 | 2021-02-25 | MEDsan GmbH | HN: MEDsan® COVID-19 IgA/IgG Rapid Test Hybrid | ||
| 00097113 | 2021-02-25 | Anchor Diagnostics GmbH | HN: Anchor SARS-CoV-2 PCR Kit (CE) | ||
| 00099045 | 2021-02-23 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clongene AP: COVID-19 Neutralization Antibody FIA |
| 00099044 | 2021-02-23 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clongene AP: COVID-19 Antigen Rapid Test Cassette (Nasal Swab) |
| 00099017 | 2021-02-23 | MedNet GmbH | Shenzhen Kisshealth Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 Neutralizing Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay) |
| 00098950 | 2021-02-23 | ProtoPharma Engineering GmbH | Sugentech inc. | Korea, Rep. | HN: SGTi-flex COVID-19 Ag AP: Antigen Schnelltest |
| 00098771 | 2021-02-23 | Luxus Lebenswelt GmbH | Ningbo Home Test Biotechnology Co.,Ltd. | China | HN: SARS-CoV-2 IgG/IgM/IgA Antibody Rapid Test(Colloidal Gold) AP: SARS-CoV-2 IgG/IgM/IgA Antibody Rapid Test(Colloidal Gold) |
| 00099057 | 2021-02-22 | FUJIFILM Europe GmbH | FUJIFILM Corporation | Japan | HN: FUJIFILM COVID-19 Ag Test AP: A SARS-CoV-2 antigen detection agent |
| 00097779 | 2021-02-19 | GA Generic Assays GmbH | HN: GA CoV-2 Antigen Rapid AP: REF 3980 |
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| 00099220 | 2021-02-18 | Pharmact GmbH | HN: BELTEST-IT AGS AP: COVID-19 Antigen-Schnelltest (Latex) |
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| 00099055 | 2021-02-18 | NIC GmbH | Safecare Biotech (Hangzhou) Co., Ltd. | China | HN: COVID-19 Antigen Rapid Test Kit(Saliva) |
| 00099024 | 2021-02-17 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: COVID-19 Antigen Rapid Test Cassette ((Nasal Swab) |
| 00098978 | 2021-02-18 | Shanghai International Holding Corporation GmbH (Europe) | Zybio Inc. | China | HN: Zybio AP: SARS-CoV-2 & Influenza A/B Antigen Assay Kit (Colloidal Gold Method) |
| 00098756 | 2021-02-18 | NIC GmbH | Suzhou Baiyuan Gene Technology Co., Ltd. (Suzhou Baiyuan Gent Co., Ltd.) | China | HN: New Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (real-time fluorescence quantitative RT-PCR method) |
| 00098112 | 2021-02-17 | Luxus Lebenswelt GmbH | Ningbo Home Test Biotechnology Co.,Ltd. | China | HN: SARS-COV-2 IgG/IgM Antibody Rapid Test(Colloidal Gold) AP: SARS-COV-2 IgG/IgM Antibody Rapid Test(Colloidal Gold) |
| 00095122 | 2020-06-25 | MedPath GmbH | Cellex, Inc. | Vereinigte Staaten von Amerika | HN: Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test |
| 00099090 | 2021-08-06 | Medical Technology Promedt Consulting GmbH | Rapid Pathogen Screening, Inc. | Vereinigte Staaten von Amerika | HN: CoviDx™ SARS-CoV-2 Rapid Antigen Test; LIAISON® Quick Detect COVID Ag Assay |
| 00098971 | 2021-02-10 | MedNet EC-REP GmbH | Qingdao Hightop Biotech Co. Ltd. | China | AP: SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test |
| 00098935 | 2021-08-03 | MedNet GmbH | AEHEALTH LIMITED | Vereinigtes Königreich | AP: COVID19 Antigen Rapid Test Kits (Colloidal Gold), COVID19 Antigen Quantitative Test Kits (Immunofluorescence Assay) |
| 00098853 | 2021-02-11 | Medical Device Safety Service GmbH | Axis-Shield Diagnostics Limited | Vereinigtes Königreich | HN: PANBIO™ SARS-CoV-2 IgG ELISA (96 Test) |
| 00098828 | 2021-02-10 | Shanghai International Holding Corporation GmbH (Europe) | Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. | China | HN: Konsung AP: COVID-19 Salivary Antigen Rapid Test Kit (Colloidal Gold) |
| 00098471 | 2021-02-10 | Shanghai International Holding Corporation GmbH (Europe) | Maccura Biotechnology Co., Ltd. | China | HN: Maccura AP: SARS-CoV-2 Fluorescent PCR Kit |
| 00099016 | 2021-02-08 | MedNet GmbH | Shenzhen Kisshealth Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay) |
| 00098993 | 2021-02-08 | mölab GmbH | HN: mö-screen SARS-CoV-2 Neutralizing Antibody (NAb) Test | ||
| 00098540 | 2021-02-08 | B.R.A.H.M.S GmbH | Thermo Fisher Scientific (Microgenics Inc.) | Vereinigte Staaten von Amerika | AP: MAS™ SARS-CoV-2 Control Kit |
| 00098067 | 2021-02-08 | MedNet GmbH | Shenzhen Kisshealth Biotechnology Co., Ltd. | China | AP: SARS-CoV-2/Human Influenza Virus A&B (Flu A&B) Antigen Test Kit (Colloidal Gold) |
| 00098065 | 2021-02-08 | MedNet GmbH | Shenzhen Kisshealth Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 Antigen Test Kit (GICA) |
| 00098835 | 2021-02-05 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: SARS-CoV-2, Flu & RSV RT-PCR Assay |
| 00098834 | 2021-02-05 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: SARS-CoV-2 Ag (CLIA) |
| 00098720 | 2021-02-05 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/ Serum/Plasma) |
| 00098674 | 2021-02-05 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: SARS-CoV-2 Neutralizing Antibody (CLIA) |
| 00098673 | 2021-02-05 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: SARS-CoV-2 & Flu A/B RT-PCR Assay |
| 00098610 | 2021-02-05 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: COVID-19+Flu A&B+RSV+Adenovirus Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab) |
| 00098609 | 2021-02-05 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: COVID-19+Flu A&B+RSV Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab) |
| 00098153 | 2021-02-05 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) |
| 00097883 | 2021-02-05 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: COVID-19 IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) |
| 00098997 | 2021-02-04 | Medical Technology Promedt Consulting GmbH | 1drop Inc. | Korea, Rep. | HN: 1copy™ COVID-19/FluA/FluB/RSV qPCR Kit (Model M25) |
| 00098996 | 2021-02-04 | Medical Technology Promedt Consulting GmbH | 1drop Inc. | Korea, Rep. | HN: 1copy™ COVID-19/FluA/FluB/RSV qPCR Kit (Model M25) |
| 00098995 | 2021-02-04 | Medical Technology Promedt Consulting GmbH | 1drop Inc. | Korea, Rep. | HN: 1copy™ COVID-19/FluA/FluB/RSV qPCR Kit (Model M25) |
| 00098938 | 2021-06-30 | Medical Technology Promedt Consulting GmbH | Princeton BioMeditech Corporation | Vereinigte Staaten von Amerika | HN: Status™ COVID-19/Flu; TekiTrust™ COVID-19/Flu A&B |
| 00098854 | 2021-02-03 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clongene AP: COVID-19 Antigen Rapid Test Cassette (Saliva) |
| 00098801 | 2021-02-03 | Caretechion GmbH | Koch Biotechnology (Beijing) Co., Ltd | China | AP: COVID-19 Antigen Rapid Test Kit |
| 00098639 | 2021-02-03 | MedNet EC-REP GmbH | Cell ID Pte Ltd. | Singapur | HN: Quiz SARS-CoV-2-NAT System AP: Replacement Kit: Positive Control |
| 00098638 | 2021-02-03 | MedNet EC-REP GmbH | Cell ID Pte Ltd. | Singapur | HN: Quiz SARS-CoV-2-NAT System AP: Replacement Kit: LAMP Beads |
| 00098628 | 2021-02-03 | MedNet EC-REP GmbH | Cell ID Pte Ltd. | Singapur | HN: Quiz SARS-CoV-2-NAT System (Kit) AP: Quiz PCR Biochip, LAMP Beads Quiz SARS-CoV-2 NAT NIC, LAMP Beads Quiz SARS-CoV-2 NAT IC, Fixed volume pipettes, Posivitve Control 1, Positive Control 2, Assay Buffer |
| 00098989 | 2021-02-02 | Roche Diagnostics GmbH | HN: SARS-CoV-2 Extraction Solution C | ||
| 00098975 | 2021-02-02 | Medical Device Safety Service GmbH | Egyptian Company for Biotechnology-Spectrum Diagnostics | Ägypten | HN: SARS COV-2 QUALITATIVE Real Time PCR KIT (DUAL PROBE ASSAY) |
| 00098974 | 2021-08-31 | Medical Device Safety Service GmbH | Daan Gene Co., Ltd. | China | HN: Detection Kit for Influenza A/B and 2019-nCoV (PCR-Fluorescence Probing) |
| 00098267 | 2021-02-02 | Pierenkemper GmbH | HN: (SARS-CoV-2) Antigen Rapid test COVIDENT COVID-19 | ||
| 00098264 | 2021-02-02 | Pierenkemper GmbH | HN: (SARS-CoV-2) Antigen Rapid test DGNI-MED COVID-19 | ||
| 00098949 | 2021-02-01 | Icon Medlab GmbH | Xiamen Boson Biotech Co., Ltd | China | HN: Rapid SARS-CoV-2 Antigen Test Card |
| 00098658 | 2021-02-01 | Bioron Diagnostics GmbH | HN: RealLine SARS-CoV-2 /Influenza A+B (A-Format BI1029-96; RealLine SARS-CoV-2 / Influenza A+B (B-format) BI1030-96 | ||
| 00098640 | 2021-02-01 | Hälsa Pharma GmbH | Mediclone Biotech Pvt. Ltd. | Indien | HN: @Sight COVID-19 Antigen Test Kit |
| 00097504 | 2021-02-01 | FRIZ Biochem GmbH | HN: COVID-19 direct RT-PCR | ||
| 00096049 | 2021-02-01 | Infinite Flex GmbH | Taizhou ZECEN Biotech Co., Ltd. | China | HN: 2019nCoV AP: ZECEN Covid19 IgG/IgM Rapid Test Cassette |
| 00098774 | 2021-01-29 | Luxus Lebenswelt GmbH | Ningbo Home Test Biotechnology Co.,Ltd. | China | HN: SARS-COV-2 Neutralizing Antibdoy Rapid Test (Colloidal Gold) AP: SARS-COV-2 Neutralizing Antibdoy Rapid Test (Colloidal Gold) |
| 00098773 | 2021-01-29 | Luxus Lebenswelt GmbH | Ningbo Home Test Biotechnology Co.,Ltd. | China | HN: SARS-COV-2 Nucleocapsid protein Antibody and Neutralizing Antibdoy Combo Rapid Test (Colloidal Gold) AP: SARS-COV-2 Nucleocapsid protein Antibody and Neutralizing Antibdoy Combo Rapid Test (Colloidal Gold) |
| 00098772 | 2021-01-29 | Luxus Lebenswelt GmbH | Ningbo Home Test Biotechnology Co.,Ltd. | China | HN: SARS-COV-2 Total Antibody and Neutralizing Antibdoy Combo Rapid Test (Colloidal Gold) AP: SARS-COV-2 Total Antibody and Neutralizing Antibdoy Combo Rapid Test (Colloidal Gold) |
| 00098770 | 2021-01-29 | Luxus Lebenswelt GmbH | Ningbo Home Test Biotechnology Co.,Ltd. | China | HN: SARS CoV-2 Antigen Rapid Test Kit(Colloidal Gold) AP: SARS CoV-2 Antigen Rapid Test Kit(Colloidal Gold) |
| 00098738 | 2021-01-29 | Luxus Lebenswelt GmbH | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. | China | HN: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) AP: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) |
| 00098931 | 2021-01-27 | nal von minden GmbH | HN: 243104N-20 NADAL® COVID-19 Ag plus Test AP: Covid-19 Ag Test |
||
| 00098928 | 2021-02-24 | Medical Device Safety Service GmbH | AccuBioTech Co., Ltd. | China | HN: ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette; ACCU-TELL® COVID-19 Antigen Cassette |
| 00098892 | 2021-01-25 | Medical Technology Promedt Consulting GmbH | General Biologicals Corporation | Taiwan | HN: GB SARS-CoV-2 Influenza A/B Multiplex PCR |
| 00096343 | 2021-01-25 | MedNet EC-REP GmbH | Henan Tuoren Medical Device Co., Ltd. | China | HN: Disposable collection tubes of virus samples |
| 00098852 | 2021-01-20 | Roche Diagnostics GmbH | HN: SARS-CoV-2 Extraction Solution | ||
| 00098839 | 2021-05-07 | Medical Technology Promedt Consulting GmbH | NanoEnTek Inc. | Korea, Rep. | HN: Influenza A&B Positive Control swab; COVID-19 Ag positive control swab; Negative control swab; COVID 19 SP Control LQ; COVID-19 total Ab LQ |
| 00098826 | 2021-01-21 | Medical Technology Promedt Consulting GmbH | Atlas Link Technology Co., Ltd. | China | HN: NOVA Test® SARS-CoV-2/Influenza A+B Antigen Combo Rapid Test Kit (Colloidal Gold Immunochromatography) |
| 00098781 | 2021-01-21 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Chemiluminescence Immunoassay) |
| 00098634 | 2021-01-21 | MedNet EC-REP GmbH | Cell ID Pte Ltd. | Singapur | HN: Quiz SARS-CoV-2-NAT System AP: POCHE, White and Black |
| 00098334 | 2021-01-20 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co.,Ltd. | China | HN: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) AP: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) |
| 00098321 | 2021-01-21 | MedNet EC-REP GmbH | Aikang Diagnostics Co., Ltd | China | HN: SARS-CoV-2 Antigen Test Kit (Immunochromatography) |
| 00098245 | 2021-01-20 | Caretechion GmbH | 3D Biomedicine Science & Technology Co., Limited. | China | AP: ANDiS FAST SARS-CoV-2 RT-qPCR Detection Kit |
| 00098200 | 2021-01-21 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: Novel Coronavirus (SARS-CoV-2) Antigen Test (Chemiluminescence Immunoassay) |
| 00098111 | 2021-01-21 | Luxus Lebenswelt GmbH | Ningbo Home Test Biotechnology Co.,Ltd. | China | HN: SARS-CoV-2 Antigen Rapid Test(Colloidal Gold) AP: SARS-CoV-2 Antigen Rapid Test(Colloidal Gold) |
| 00098110 | 2021-01-21 | Luxus Lebenswelt GmbH | Ningbo Home Test Biotechnology Co.,Ltd. | China | HN: SARS-CoV-2 +FluA&B Antigen Combo Rapid Test(Colloidal Gold) AP: SARS-CoV-2 +FluA&B Antigen Combo Rapid Test(Colloidal Gold) |
| 00097563 | 2021-01-20 | MEXACARE GmbH | HN: QuickTestCorona COVID-19 & Influenza A+B Ag Combo-Schnelltest | ||
| 00096929 | 2021-01-20 | MEXACARE GmbH | HN: COVID-19 Antigen Schnelltest (Nasen-/Rachenabstrich) | ||
| 00098842 | 2021-01-18 | Medical Device Safety Service GmbH | AccuBioTech Co., Ltd. | China | HN: ACCU-TELL® SARS-CoV-2 + Flu A&B Antigen Combo Cassette |
| 00098653 | 2021-01-18 | AmplexDiagnostics GmbH | HN: eazyplex SARS-CoV-2 | ||
| 00098182 | 2021-01-18 | Ram Group DE GmbH | HN: ThEA | ||
| 00098798 | 2021-01-15 | ulti med Products (Deutschland) GmbH | HN: COVID-19 Antigen Saliva Test Card | ||
| 00098657 | 2021-01-15 | Medical Technology Promedt Consulting GmbH | Jei Daniel (JD) Biotech Corp. | China | HN: SARS-COV-2 and Influenza A+B Ag Combo Rapid Test |
| 00098422 | 2021-01-15 | EUROIMMUN Medizinische Labordiagnostika AG | AP: SARS-CoV-2-Antigen-ELISA | ||
| 00098311 | 2021-01-15 | EUROIMMUN Medizinische Labordiagnostika AG | AP: EURORealTime SARS-CoV-2/Influenza A/B | ||
| 00098725 | 2021-01-12 | KTR Europe GmbH | DowGene Co., Ltd. | Korea, Rep. | HN: DG-CV0401 AP: Dow NETPlex™ SARS-CoV-2 RT-PCR Kit |
| 00098671 | 2021-01-13 | mdi Europa GmbH | Precision Biosensor Inc. | Korea, Rep. | AP: Coronavirus - RT & POC |
| 00098670 | 2021-01-13 | mdi Europa GmbH | Fluidigm Corporation | Vereinigte Staaten von Amerika | AP: Coronavirus - NA Reagents |
| 00098654 | 2021-01-13 | mdi Europa GmbH | Metas Biomedical Inc. | Taiwan | AP: OTHER RETROVIRUSES RAPID TESTS |
| 00098545 | 2021-01-14 | Mast Diagnostica GmbH | HN: Mast Isoplex SARS-CoV-2 | ||
| 00098226 | 2021-01-12 | KTR Europe GmbH | MEDIAN Diagnostics lnc. | Korea, Rep. | HN: MDX-CVD-22 AP: COVID 19 Ag Rapid Test Kit |
| 00097958 | 2021-01-12 | KTR Europe GmbH | MEDIAN Diagnostics lnc. | Korea, Rep. | HN: MDX-CVD-21 AP: COVID-19 IgG/IgM Rapid Test Kit |
| 00098808 | 2021-01-12 | KTR Europe GmbH | KOREA GENOME INFORMATION INSTITUTE | Korea, Rep. | HN: KGIC COVID-19 Antigen (Ag) Kit AP: COVID-19 Antigen (Ag) Kit |
| 00098807 | 2021-01-12 | KTR Europe GmbH | Eubiologics Co., Ltd. | Korea, Rep. | HN: EuViroQ™ COVID-19 Ag Rapid Kit AP: COVID-19 Ag Rapid Kit |
| 00098783 | 2021-01-12 | Servoprax GmbH | HN: Cleartest Corona Pro AP: Cleartest Corona |
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| 00097941 | 2021-01-12 | Labor Kneißler GmbH & Co. KG | Microbiologique Inc. | Vereinigte Staaten von Amerika | HN: IEH Nucleic Acid Extraction Reagent Kit (For EU) REF PM-23 |
| 00097931 | 2021-01-12 | Labor Kneißler GmbH & Co. KG | Microbiologique Inc. | Vereinigte Staaten von Amerika | HN: IEH SARS-CoV-2 RT-PCR Test |
| 00098804 | 2021-02-05 | Medical Device Safety Service GmbH | Access Bio Korea, Inc. | Korea, Rep. | HN: CareStart™ COVID-19 Ag; CareStart™ COVID-19 IgM/IgG |
| 00098246 | 2021-01-11 | JaviTech e.K. | ImmuneMed, Inc. | Korea, Rep. | HN: ImmuneMed COVID-19 IgM/IgG Rapid AP: Rapid Diagnostic Kits for infectious Diseases |
| 00098758 | 2021-01-08 | Luxus Lebenswelt GmbH | Zhejiang Bona Biotechnology Co.,Ltd. | China | HN: Virus Sampling Kit AP: Virus Sampling Kit |
| 00098656 | 2021-09-14 | Medical Technology Promedt Consulting GmbH | KH Medical Co., Ltd. | Korea, Rep. | HN: RADI Flu-SC2 Ag Rapid Test |
| 00098578 | 2021-03-22 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | HN: Lifotronic AP: SARS-CoV-2 Neutralization Ab(Lateral Flow Immunoassay) |
| 00098577 | 2021-01-08 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | HN: Lifotronic AP: SARS-CoV-2 Neutralization Ab (eCLIA) |
| 00098258 | 2021-01-08 | R-Biopharm AG | HN: RIDA®GENE Flu & SARS-CoV-2 | ||
| 00098794 | 2021-01-07 | Medical Device Safety Service GmbH | WOORIDUL PHARMACEUTICAL Co., Ltd. | Korea, Rep. | HN: fineGENE™ N-CoV RT-PCR kit; fineGENE™ COVID-19 RT-PCR kit |
| 00098793 | 2021-01-18 | Medical Device Safety Service GmbH | WOORIDUL PHARMACEUTICAL Co., Ltd. | Korea, Rep. | HN: findUS™ COVID-19 antigen ; findUS™ COVID-19 IgM / IgG |
| 00098655 | 2021-04-06 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Sejoy Electronics& Instruments Co., Ltd. | China | HN: Sejoy AP: SARS-CoV-2 Antigen Rapid Test Cassette |
| 00098313 | 2021-01-06 | Immundiagnostik AG | HN: PreventID® SARS-CoV-2 Antigen AP: SARS-CoV-2 Antigen Schnelltest |
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| 00098098 | 2021-01-07 | Shanghai International Holding Corporation GmbH (Europe) | Zybio Inc. | China | HN: Zybio AP: SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method) |
| 00097950 | 2021-01-07 | Shanghai International Holding Corporation GmbH (Europe) | Zybio Inc. | China | HN: Zybio AP: SARS-CoV-2 & Influenza A/B Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) |
| 00097683 | 2021-01-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co.,Ltd. | China | HN: Mindray AP: SARS-CoV-2 S-RBD IgG Antibody Control (L) |
| 00097682 | 2021-01-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co.,Ltd. | China | HN: Mindray AP: SARS-CoV-2 S-RBD IgG Antibody Control (H) |
| 00097681 | 2021-01-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co.,Ltd. | China | HN: Mindray AP: Severe Acute Respiratory Syndrome Coronavirus 2 S-RBD IgG (CLIA) |
| 00097680 | 2021-01-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co.,Ltd. | China | HN: Mindray AP: SARS-CoV-2 NT Antibody Control (L) |
| 00097679 | 2021-01-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | HN: Mindray AP: SARS-CoV-2 NT Antibody Control (H) |
| 00097678 | 2021-01-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | HN: Mindray AP: Severe Acute Respiratory Syndrome Coronavirus 2 neutralizing antibody (CLIA) |
| 00098424 | 2021-01-04 | Medical Technology Promedt Consulting GmbH | OPTI Medical Systems, Inc. | Vereinigte Staaten von Amerika | HN: OPTI SARS-CoV-2 Total Antibody Test |
| 00097559 | 2021-01-04 | Shanghai International Holding Corporation GmbH (Europe) | Healgen Scientific Limited Liability Company | Vereinigte Staaten von Amerika | HN: Healgen AP: Rapid COVID-19 Antigen Test |
| 00098543 | 2020-12-30 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Competition Up-converting Phosphor Immunochromatographic Technology) |
| 00098636 | 2020-12-29 | MedNet EC-REP GmbH | Wuhan EasyDiagnosis Biomedicine Co., Ltd. | China | AP: COVID-19 & Influenza A/B Nucleic Acid Test Kit |
| 00098652 | 2020-12-28 | Luxus Lebenswelt GmbH | Zhejiang Bona Biotechnology Co.,Ltd. | China | HN: SARS-CoV-2 Antigen Rapid Test Kit AP: SARS-CoV-2 Antigen Rapid Test Kit |
| 00098496 | 2020-12-22 | mdi Europa GmbH | Abnova (Taiwan) Corporation | Taiwan | AP: Coronavirus |
| 00098580 | 2021-09-16 | Medical Device Safety Service GmbH | CTK Biotech, Inc. | Vereinigte Staaten von Amerika | HN: Positivia COVID-19 IgG/IgM Rapid Test External Control Kit; Positivia Dengue Ag Rapid Test External Control Kit; Positivia COVID-19 Ag Rapid Test External Control Kit; Positivia Dengue IgG Rapid Test External Control Kit |
| 00098579 | 2020-12-21 | Medical Device Safety Service GmbH | CTK Biotech, Inc. | Vereinigte Staaten von Amerika | HN: OnSite COVID-19 + Influenza A/B Ag Rapid Test; Aria COVID-19 + Influenza A/B Ag Rapid Test |
| 00098562 | 2020-12-21 | Eurofins GeneScan Technologies GmbH | HN: GSD NovaPrime® IVD SARS-CoV-2 Mplex FLA (Sanger) | ||
| 00098472 | 2021-08-11 | Medical Device Safety Service GmbH | WELLS BIO, INC. | Korea, Rep. | HN: careUS™ COVID-19 antigen; careUS™ COVID-19 antigen Single Kit; careUS™ COVID-19 IgM / IgG Ab; findUS™ COVID-19 IgM / IgG Ab |
| 00098446 | 2020-12-21 | Medical Device Safety Service GmbH | PlexBio Co., Ltd. | Taiwan | HN: IntelliPlex™SARS-CoV-2/Flu kit |
| 00098254 | 2021-01-07 | Medical Device Safety Service GmbH | MiRXES Pte Ltd | Singapur | HN: MiRXES Fortitude SARS-CoV-2 & FluA/B Test |
| 00098500 | 2020-12-18 | BAG Diagnostics GmbH | HN: ViroQ SARS-FluA/B-RSV | ||
| 00098406 | 2020-12-18 | Institut Virion/Serion GmbH | HN: Serion ELISA control SARS-Cov-2 IgM | ||
| 00096661 | 2020-12-18 | Institut Virion/Serion GmbH | HN: SERION ELISA agile SARS-CoV-2 IgM | ||
| 00098271 | 2020-12-14 | NanoRepro AG | HN: VICE SARS-CoV-2 Antigen Schnelltest | ||
| 00097301 | 2020-12-14 | Shanghai International Holding Corporation GmbH (Europe) | Changsha Sinocare Inc. | China | HN: Sinocare AP: SARS-CoV-2 IgM/IgG Antibody Test Kit |
| 00098209 | 2020-12-11 | Luxus Lebenswelt GmbH | Shenzhen Lvshiyuan Biotechnology Co., Ltd. | China | HN: Flu A & Flu B & COVID-19 Ag Rapid Test AP: Flu A & Flu B & COVID-19 Ag Rapid Test |
| 00098305 | 2020-12-10 | Roche Diagnostics GmbH | HN: PreciControl SARS-CoV-2 Antigen | ||
| 00098304 | 2020-12-10 | Roche Diagnostics GmbH | HN: Elecsys SARS-CoV-2 Antigen | ||
| 00098270 | 2020-12-10 | DRG Instruments GmbH | HN: COVID-19 Ag / Influenza A+B Ag Rapid Test | ||
| 00098263 | 2020-12-10 | mdi Europa GmbH | Nano-Ditech Corporation | Vereinigte Staaten von Amerika | AP: OTHER OTHER VIROLOGY RAPID TESTS |
| 00098257 | 2020-12-10 | MedNet GmbH | SurExam Bio-Tech Co., Ltd | China | AP: SARS-CoV-2 Antigen Rapid Test |
| 00098243 | 2020-12-10 | nal von minden GmbH | HN: dedicio® COVID-19 Ag+Influenza A/B plus Test AP: Covid-19 Ag +Influenza A/B plus Test |
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| 00098242 | 2020-12-10 | nal von minden GmbH | HN: dedicio® COVID-19 Ag plus Test AP: Covid-19 Ag Test |
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| 00098212 | 2020-12-10 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: SARS-CoV-2 and Flu A/B Antigen Combo Rapid Test (Colloidal Gold) |
| 00098162 | 2020-12-16 | mdi Europa GmbH | Cue Health Inc. | Vereinigte Staaten von Amerika | AP: OTHER VIROLOGY - NA REAGENTS |
| 00098073 | 2020-12-10 | DRG Instruments GmbH | HN: COVID-19 Antigen | ||
| 00097978 | 2020-12-09 | NIC GmbH | Safecare Biotech (Hangzhou) Co., Ltd. | China | HN: Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19) |
| 00097702 | 2021-02-10 | MedNet GmbH | ACON Biotech (Hangzhou) Co., Ltd. | China | HN: FIAflex AP: SARS-CoV-2 Antigen FIA |
| 00098240 | 2020-12-08 | RD-RatioDiagnostics GmbH | Diabetomics Inc | Vereinigte Staaten von Amerika | HN: CoVAbScreen SARS-CoV-2 Antibody Test AP: 2030 |
| 00097956 | 2020-12-08 | Shanghai International Holding Corporation GmbH (Europe) | CITUS DIAGNOSTICS INC. | Kanada | HN: CITUS AP: COVID-19 Antigen Rapid Test Cassette(Oral Fluid) |
| 00097954 | 2020-12-08 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: COVID-19 Antigen Rapid Test Cassette (Oral Fluid) |
| 00097871 | 2020-12-08 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2/Influenza A+B Antigen Combo Test kit (Colloidal Gold) |
| 00097868 | 2020-12-08 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Tisenc Medical Devices Co., Ltd. | China | HN: Tisenc AP: SARS-CoV-2 Antigen (CLIA) |
| 00097555 | 2020-12-08 | Shanghai International Holding Corporation GmbH (Europe) | Co-Innovation Biotech Co. Ltd. | China | HN: Co-Innovation AP: One Step 2019-Novel Coronavirus (2019-nCoV) Antigen Test Cassette |
| 00097410 | 2020-12-04 | Medwheat Tech Service GmbH | HangZhou Lifereal biotechnology CO.,Ltd | China | HN: 2019-nCoV/Influenza A/Influenza B Nucleic Acid (RNA) POCT Detection Kit (AIGS real-time fluorescent PCR method) |
| 00095650 | 2020-12-03 | Luxus Lebenswelt GmbH | Anhui Anlong Gene Technology Co., Ltd. | China | HN: Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR) AP: Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR) |
| 00095597 | 2020-12-03 | Luxus Lebenswelt GmbH | AnHui Iprocom Biotechnology Co., Ltd | China | HN: New coronavirus（COVID-19）IgM/IgG antibody rapid detection kit AP: New coronavirus（COVID-19）IgM/IgG antibody rapid detection kit |
| 00098164 | 2021-09-14 | Medical Technology Promedt Consulting GmbH | KH Medical Co., Ltd. | Korea, Rep. | HN: RADI Flu-SC2 Detection Kit |
| 00098114 | 2020-11-30 | Medical Technology Promedt Consulting GmbH | PRIME4DIA Co., Ltd. | Korea, Rep. | HN: P4DETECT COVID-19 Ag/Flu |
| 00098108 | 2020-11-30 | LIONEX GmbH | HN: COVID-19 Ag Rapid Test / COVID-19 Ag Schnelltest | ||
| 00098102 | 2020-11-30 | Aesku.Diagnostics GmbH & Co. KG | HN: AESKU.RAPID SARS-CoV-2 | ||
| 00097353 | 2020-11-30 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: Novel Coronavirus (2019-nCoV) IgM Test (Colloidal Gold) |
| 00098134 | 2020-11-27 | mdi Europa GmbH | Nano-Ditech Corporation | Vereinigte Staaten von Amerika | AP: OTHER OTHER VIROLOGY RAPID TESTS |
| 00098107 | 2020-11-27 | MedNet EC-REP GmbH | Labnovation Technologies, Inc. | China | AP: SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit (Immunochromatography) |
| 00098099 | 2020-11-27 | NanoRepro AG | HN: NANOREPRO SARS-CoV-2 Antigen Schnelltest AP: SARS-CoV-2 Antigen Schnelltest |
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| 00098097 | 2020-11-27 | MedNet EC-REP GmbH | Qingdao Hightop Biotech Co. Ltd. | China | AP: SARS-CoV-2 and Influenza A+B Antigen Rapid Test |
| 00097734 | 2021-05-05 | MedNet EC-REP GmbH | Wuhan EasyDiagnosis Biomedicine Co., Ltd. | China | HN: eDiagnosis, VICE medical, EUROPAPA AP: COVID-19 (SARS-CoV-2) Antigen Test Kit; COVID-19 Antigen Rapid Test Kit (Saliva/Swabs) |
| 00097495 | 2020-11-27 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) |
| 00097186 | 2021-01-21 | MedNet EC-REP GmbH | TaiDoc Technology Corporation | Taiwan | HN: VTRUST TD-4531, FORA TD-4531, TESTAmed Diagnostics TD-4531 AP: COVID-19 Antigen Rapid Test |
| 00098100 | 2020-11-26 | Medical Device Safety Service GmbH | NanoBioLife Inc. | Korea, Rep. | HN: NanoCare™ COVID-19 Antigen (Ag) Kit |
| 00096981 | 2020-12-03 | Protzek Gesellschaft für biomedizinische Technik mbH | HN: EP COVID-19 Antikörpertest (IgM/IgG) AP: Nachweis IgG und IgM gegen Spike Protein SARS-CoV-2 |
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| 00097764 | 2020-11-24 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co.,Ltd. | China | HN: SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab) AP: SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab) |
| 00097435 | 2020-11-24 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co.,Ltd. | China | HN: Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography) AP: Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography) |
| 00097983 | 2020-11-23 | Institut Virion/Serion GmbH | HN: Serion ELISA control SARS-Cov-2 IgG | ||
| 00097982 | 2020-11-23 | Institut Virion/Serion GmbH | HN: Serion ELISA control SARS-Cov-2 IgA | ||
| 00098078 | 2021-09-14 | Medical Technology Promedt Consulting GmbH | KH Medical Co., Ltd. | Korea, Rep. | HN: RADI COVID-19 Ag Rapid Test; RADI Flu-SC2 Ag Rapid Test; RADI COVID-19 IgG/IgM Rapid Test |
| 00098062 | 2021-08-09 | Medical Technology Promedt Consulting GmbH | NB POSTECH, Inc. | Korea, Rep. | HN: CHEXEL™ COVID-19 IgM/IgG (model: GQLAG, GQLAGH, GQLAGM); CHEXEL™ COVID-19 Ag (model: GQLAH1, GQLAHH1, GQLAHM1); EDGC™ COVID-19 Ag Test (model: GQLAI1, GQLAI); RapiSure™ COVID-19 Antigen Test (model: GQLAIB1, GQLAIB); BAROZen™ COVID-19 Ag (model: GQLAHZ1) |
| 00098011 | 2020-11-20 | Bosch Healthcare Solutions GmbH | HN: Vivalytic CoV | ||
| 00097744 | 2020-11-20 | Luxus Lebenswelt GmbH | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. | China | HN: Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) AP: Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) |
| 00097743 | 2020-11-20 | Luxus Lebenswelt GmbH | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. | China | HN: COVID-19 (SARS-CoV-2) Antibody & Antigen Combo Test Kit (Colloidal Gold) AP: COVID-19 (SARS-CoV-2) Antibody & Antigen Combo Test Kit (Colloidal Gold) |
| 00097977 | 2020-11-19 | HAIN LIFESCIENCE GmbH | HN: FluoroType® SARS-CoV-2/Flu/RSV VER 1.0 | ||
| 00097913 | 2020-11-19 | MedNet EC-REP GmbH | Beijing Beier Bioengineering Co., Ltd | China | AP: COVID-19 & Influenza A/B Rapid Test Kit |
| 00097172 | 2021-02-26 | MedNet EC-REP GmbH | Qingdao Hightop Biotech Co. Ltd. | China | AP: SARS-CoV-2 Antigen Rapid Test (Immunochromatography) |
| 00097943 | 2020-11-17 | Medical Technology Promedt Consulting GmbH | PCL. Inc. | Korea, Rep. | HN: PCLMD ABC multi RT-PCR (Flu A/B + Covid-19) |
| 00097793 | 2020-11-17 | Icon Medlab GmbH | Beijing Lepu Medical Technology Co., Ltd. | China | HN: SARS-CoV-2 Antigen Rapid Test Kit |
| 00097782 | 2020-11-17 | Günter Keul GmbH | HN: Keul-o-test COVID-19 Antigen-Schnelltestkassette AP: COVID-19 Antigen-Schnelltestkassette |
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| 00097497 | 2020-11-17 | Günter Keul GmbH | HN: Keul-o-test® COVID-19 und Influenza A+B Antigen Combotest AP: SARS-CoV-2 und Influenza A+B Antigen Combotest |
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| 00097483 | 2021-03-16 | MedNet GmbH | Beijing Diagreat Biotechnologies Co., Ltd | China | HN: 2019-nCoV specific test |
| 00096452 | 2020-11-17 | Shanghai International Holding Corporation GmbH (Europe) | Shanghai Chemtron Biotech.Co., Ltd. | China | HN: Chemtron AP: Novel Coronavirus (2019-nCoV) IgG Antibody Diagnostic Kit |
| 00097441 | 2020-11-16 | AXIOM Gesellschaft für Diagnostica und Biochemica mbH | HN: COVID-19 Ag Rapid Test Card | ||
| 00097440 | 2020-11-16 | AXIOM Gesellschaft für Diagnostica und Biochemica mbH | HN: COVID-19 IgG/IgM Rapid Test Kit | ||
| 00097439 | 2020-11-16 | AXIOM Gesellschaft für Diagnostica und Biochemica mbH | HN: SARS-CoV-2 RT- PCR Kit | ||
| 00097438 | 2020-11-16 | AXIOM Gesellschaft für Diagnostica und Biochemica mbH | HN: SARS-CoV-2 Ab ELISA | ||
| 00097396 | 2020-11-16 | AXIOM Gesellschaft für Diagnostica und Biochemica mbH | HN: SARS-CoV-2 IgM ELISA | ||
| 00097906 | 2020-11-13 | ulti med Products (Deutschland) GmbH | HN: COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) | ||
| 00097912 | 2020-11-11 | NanoRepro AG | LABNOVATION TECHNOLOGIES,INC | China | HN: LABNOVATION SARS-CoV-2 Antigen Schnelltest |
| 00097911 | 2020-11-11 | JaviTech e.K. | CTCBIO INC. | Korea, Rep. | HN: CTC™ COVID-19 IgM/IgG Combo Test |
| 00097905 | 2020-11-11 | mdi Europa GmbH | Firstep Bioresearch, Inc. | Taiwan | AP: OTHER OTHER VIROLOGY RAPID TESTS |
| 00097850 | 2020-11-13 | mdi Europa GmbH | Co-Diagnostics, Inc. | Vereinigte Staaten von Amerika | AP: OTHER VIROLOGY - NA REAGENTS |
| 00097727 | 2020-11-11 | Shanghai International Holding Corporation GmbH (Europe) | CITUS DIAGNOSTICS INC. | Kanada | HN: CITUS AP: COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab) |
| 00097558 | 2020-11-11 | MedNet EC-REP GmbH | Aikang Diagnostics Co., Ltd | China | HN: Novel Coronavirus (SARS-CoV-2) IgG/IgM Antibody Combined Test Kit (Colloidal Gold Immunochromatographic Assay) |
| 00097502 | 2020-11-11 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab) |
| 00097470 | 2020-11-11 | Shanghai International Holding Corporation GmbH (Europe) | CITUS DIAGNOSTICS INC. | Kanada | HN: CITUS AP: Novel Coronavirus SARS-CoV-2 Antigen Rapid Test Cassette (Fluorescence immunochromatography) |
| 00097459 | 2020-11-11 | Shanghai International Holding Corporation GmbH (Europe) | CITUS DIAGNOSTICS INC. | Kanada | HN: CITUS AP: COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) |
| 00097457 | 2020-11-11 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) |
| 00097248 | 2020-11-11 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: Novel Coronavirus SARS-CoV-2 Antigen Rapid Test Cassette (Fluorescence immunochromatography) |
| 00097880 | 2020-11-10 | MP Biomedicals Germany GmbH | HN: Rapid SARS-CoV-2 Antigen Test Card | ||
| 00097565 | 2021-04-26 | MedNet EC-REP GmbH | Artron Laboratories Inc. | Kanada | AP: COVID-19 Antigen Test |
| 00097907 | 2020-11-09 | Medical Technology Promedt Consulting GmbH | Bioneer Corporation | Korea, Rep. | HN: AccuPower® RV1 Multiplex Kit; AccuPower® RV1 Real-Time RT-PCR-Kit |
| 00097792 | 2020-11-09 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) |
| 00097791 | 2020-11-09 | Convergent Technologies GmbH & Co. KG | HN: Convergys® COVID-19 Antigen Rapid Test | ||
| 00097726 | 2020-11-09 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clongene AP: COVID-19/Influenza A+B Antigen Combo Rapid Test |
| 00097426 | 2020-11-09 | MedNet EC-REP GmbH | Labnovation Technologies, Inc. | China | HN: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) |
| 00097369 | 2020-11-09 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotest AP: COVID-19 Antigen Rapid Test Cassette (Swab/ Aspirate) |
| 00097581 | 2020-11-06 | NIC GmbH | Safecare Biotech (Hangzhou) Co., Ltd. | China | HN: COVID-19 Antigen Rapid Test Kit(Swab) AP: COVID-19 Antigen Rapid Test Kit(Swab) |
| 00097879 | 2020-11-04 | mdi Europa GmbH | Plexense, Inc. | Korea, Rep. | AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION |
| 00097829 | 2020-11-04 | Medical Device Safety Service GmbH | Megna Health Inc. | Vereinigte Staaten von Amerika | HN: Rapid COVID-19 Antigen Qualitative Test Kit |
| 00097826 | 2020-11-04 | Medical Device Safety Service GmbH | Megna Health Inc. | Vereinigte Staaten von Amerika | HN: Rapid COVID-19 IgM/IgG Combo Test Kit |
| 00097814 | 2020-11-20 | Medical Device Safety Service GmbH | Aalto Scientific, Ltd. | Vereinigte Staaten von Amerika | HN: Control LQ COVID-19 Antibodies; Control LQ COVID-19 IgG + IgM Antibodies |
| 00097799 | 2021-01-26 | Medical Technology Promedt Consulting GmbH | Sugentech, Inc. | Korea, Rep. | HN: SGT ANTI-SARS-COV-2 TOTAL AB ELISA; SGT SARS-CoV-2 In Vitro Neutralizing Antibody Test (IVnAT) |
| 00097777 | 2021-07-02 | Medical Technology Promedt Consulting GmbH | ARISTA Biotech Pte. Ltd. | Singapur | HN: ARISTA™ COVID-19 Antigen Rapid Test AP: Covid-19 Antigen Test |
| 00097769 | 2021-03-15 | Medical Technology Promedt Consulting GmbH | ACEBiomed, Inc. | Korea, Rep. | HN: Product Name: COVID-19 Real-time RT-PCR Kit, Model Name: Palm PCR™ COVID-19 Fast Real-Time RT-PCR Kit; Palm PCR™ Fast COVID-19 Assay |
| 00097761 | 2021-03-05 | Medical Technology Promedt Consulting GmbH | ACEBiomed, Inc. | Korea, Rep. | HN: Product Name: COVID-19 IgM/IgG Rapid Kit, Model Name: ACEBiomed COVID-19 IgM/IgG; Product Name: COVID-19 Ag Rapid Kit, Model Name: ABM COVID-19 Ag |
| 00097429 | 2020-11-05 | Shanghai International Holding Corporation GmbH (Europe) | Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. | China | HN: Konsung AP: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) |
| 00096110 | 2020-11-04 | Luxus Lebenswelt GmbH | Health Port Biotech, Co., Ltd. | China | HN: COVID-19 IgM/IgG Antibody Combo Test Kit AP: COVID-19 IgM/IgG Antibody Combo Test Kit |
| 00097820 | 2020-11-03 | Spindiag GmbH | HN: Rhonda SARS-CoV-2 disk | ||
| 00097576 | 2020-11-03 | Caretechion GmbH | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | China | AP: Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Spike RBD Antibody |
| 00097575 | 2020-11-03 | Caretechion GmbH | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | China | AP: Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel Coronavirus(SARS-CoV-2) |
| 00097066 | 2020-11-03 | Caretechion GmbH | Guangzhou Decheng Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 Ag & FLU A/B Combo Rapid Test (Immunochromatography) |
| 00097051 | 2020-11-03 | Caretechion GmbH | Guangzhou Decheng Biotechnology Co., Ltd. | China | AP: Digital SARS-CoV-2 Antibody Rapid Test Kit |
| 00097049 | 2020-11-03 | Caretechion GmbH | Guangzhou Decheng Biotechnology Co., Ltd. | China | AP: Digital SARS-CoV-2 Ag Rapid Test Kit(Immunochromatography) |
| 00096558 | 2020-11-02 | Shanghai International Holding Corporation GmbH (Europe) | Shanghai Chemtron Biotech.Co.,Ltd. | China | HN: Chemtron AP: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) |
| 00097750 | 2020-10-30 | NanoRepro AG | Azure Biotech, Inc | Vereinigte Staaten von Amerika | HN: Dia Sure COVID-19 Antigen Schnelltest |
| 00097796 | 2020-10-28 | MIKROGEN GmbH | HN: ampliCube Respiratory Flu & SARS-CoV-2 LC | ||
| 00097795 | 2020-10-28 | MIKROGEN GmbH | HN: ampliCube Respiratory Flu & SARS-CoV-2 | ||
| 00097732 | 2020-10-29 | Devidia GmbH | HN: DEDIATEST 2019-nCoV-Antigen Rapid Test | ||
| 00097698 | 2021-01-13 | Intermundien-Lemon Europe GmbH | Ensol Biosciences Inc. | Korea, Rep. | HN: Ensol Specimen Collection and Transport System (EnTM KIT) |
| 00097340 | 2020-10-29 | Luxus Lebenswelt GmbH | Blue Cross Bio-Medical (Beijing) Co., Ltd. | China | HN: COVID-19 Antigen Test AP: COVID-19 Antigen Test |
| 00095401 | 2020-10-29 | Luxus Lebenswelt GmbH | Nanjing Synthgene Medical Technology Co., Ltd. | China | HN: COVID-19 IgM/gG antibody detection kit (colloidal gold method) AP: COVID-19 IgM/gG antibody detection kit (colloidal gold method) |
| 00097724 | 2020-10-27 | mdi Europa GmbH | Precision Biosensor Inc. | Korea, Rep. | AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION |
| 00097699 | 2020-10-27 | MedNet GmbH | Trentron Biomedical Ltd. | Taiwan | HN: VitaPCR Influenza/SARS-CoV-2 (Flu/SC2) Assay |
| 00097589 | 2020-10-27 | MedNet EC-REP GmbH | Jiangsu Bioperfectus Technologies Co., Ltd. | China | AP: COVID-19 Coronavirus and Influenza A/B Virus Real Time PCR Kit |
| 00097551 | 2020-10-27 | AIDA GmbH | HN: SARS-CoV-2 S1 IgM | ||
| 00097550 | 2020-10-27 | AIDA GmbH | HN: SARS-CoV-2 S1 IgG | ||
| 00097549 | 2020-10-27 | AIDA GmbH | HN: SARS-CoV-2 S1 IgA | ||
| 00097525 | 2020-10-27 | ulti med Products (Deutschland) GmbH | HN: COVID-19 and Influenza A+B Combo Test | ||
| 00097351 | 2020-10-27 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: Novel Coronavirus (2019-nCoV) IgG Test (Colloidal Gold) |
| 00097336 | 2021-08-23 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | HN: Hotgen Biotech, CORA CHECK-19 AP: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) |
| 00097738 | 2021-07-02 | Medical Device Safety Service GmbH | ACON Laboratories, Inc. | Vereinigte Staaten von Amerika | HN: Flowflex™ SARS-CoV-2 Antigen Rapid Test; Ritter® Easy Check SARS-CoV-2 Antigen Rapid Test; Flowflex™ SARS-CoV-2 Antigen Rapid Test Strip; Flowflex™ SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva); Flowflex™ SARS-CoV-2 Neutralizing Antibody Rapid Test |
| 00097731 | 2020-11-17 | ScheBo Biotech AG | HN: ScheBo SARS CoV-2 Quick Antigen AP: ScheBo SARS CoV-2 Quick Antigen |
||
| 00097728 | 2020-10-22 | MP Biomedicals Germany GmbH | HN: COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) | ||
| 00097103 | 2020-10-22 | BioeXsen GmbH | HN: BioeXsen SARS-CoV-2 RT PCR | ||
| 00097696 | 2020-11-19 | Servoprax GmbH | HN: Cleartest Corona-Antigen AP: Cleartest Corona-Antigen |
||
| 00097588 | 2021-02-11 | Medical Device Safety Service GmbH | ACON Laboratories, Inc. | Vereinigte Staaten von Amerika | HN: Foresight® SARS-CoV-2 IgG EIA Test Kit; Foresight® SARS-CoV-2 IgM EIA Test Kit; FIAflex™ SARS-CoV-2 Antigen FIA |
| 00097027 | 2020-10-20 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 Ag Diagnostic Test Kit (Immuo-fluorescence) |
| 00096601 | 2020-10-20 | Shanghai International Holding Corporation GmbH (Europe) | Guangdong Hecin Scientific, Inc. | China | HN: Hecin AP: SARS-CoV-2 Real-time PCR Assay Kit (lyophilized) |
| 00096207 | 2020-10-20 | Shanghai International Holding Corporation GmbH (Europe) | Guangdong Hecin Scientific, Inc. | China | HN: Hecin AP: COVID-19 IgG Antibody Test Kit (colloidal gold method) |
| 00095685 | 2020-10-20 | TEERX Lifescience UG (haftungsbeschränkt) | HN: Coronavirus Abstrich-Kit | ||
| 00097501 | 2020-10-19 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | HN: Lifotronic AP: SARS-CoV-2 Antigen (GICA) |
| 00096874 | 2020-10-19 | AB Diagnostic Systems GmbH | RPC Diagnostic Systems Ltd. | Russische Föderation | HN: DS-EIA-ANTI-SARS-CoV-2-G |
| 00097557 | 2020-10-16 | nal von minden GmbH | AP: Covid-19 Ag+Influenza A/B Test | ||
| 00097553 | 2020-10-16 | Medical Technology Promedt Consulting GmbH | 3B BlackBio Biotech India Ltd. | Indien | HN: TRUPCR®SARS-CoV-2 RT qPCR Kit V-2.0(I) |
| 00097245 | 2020-10-16 | mölab GmbH | HN: mö-screen Corona Antigen Test | ||
| 00097580 | 2020-10-15 | DRG Instruments GmbH | HN: SARS-CoV-2 (RBD) IgG ELISA | ||
| 00097523 | 2020-10-15 | DRG Instruments GmbH | HN: SARS-CoV-2 (RBD) Total Ab ELISA | ||
| 00097519 | 2020-10-15 | Aesku.Diagnostics GmbH & Co. KG | HN: AESKULISA SARS-CoV-2 S1 IgM | ||
| 00097518 | 2020-10-15 | Aesku.Diagnostics GmbH & Co. KG | HN: AESKULISA SARS-CoV-2 S1 IgG | ||
| 00097515 | 2020-10-15 | Aesku.Diagnostics GmbH & Co. KG | HN: AESKULISA SARS-CoV-2 S1 IgA | ||
| 00097498 | 2020-10-15 | BAG Diagnostics GmbH | HN: ViroQ Rapid SARS-CoV-2 | ||
| 00097337 | 2020-10-13 | MedNet GmbH | Beijing Hotgen Biotech Co., Ltd. | China | AP: Novel Coronavirus 2019-nCoV Antigen Test (Up-converting Phosphor Immunochromatographic Technology) |
| 00097199 | 2020-10-12 | Genome Identification Diagnostics GmbH | HN: CoV-iSpot | ||
| 00097532 | 2021-05-17 | Medical Technology Promedt Consulting GmbH | SG Medical Inc. | Korea, Rep. | HN: GeneTM; ALLTM; ALLTM Set; GeneTM Set; SELLTM Set |
| 00097509 | 2021-03-01 | Medical Technology Promedt Consulting GmbH | Atlas Link Technology Co., Ltd. | China | HN: NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold Immunochromatography); NOVA Test® SARS-CoV-2/Influenza A+B Antigen Combo Rapid Test Kit (Colloidal Gold Immunochromatography); Vaperon™ SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold Immunochromatography) |
| 00097520 | 2021-09-22 | Bosch Healthcare Solutions GmbH | HN: Vivalytic SARS-CoV-2 Pooling | ||
| 00097516 | 2020-10-16 | mdi Europa GmbH | Nano-Ditech Corporation | Vereinigte Staaten von Amerika | AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION |
| 00097514 | 2021-08-31 | Medical Device Safety Service GmbH | Daan Gene Co., Ltd. | China | HN: Detection Kit for 2019-nCoV (PCR-Fluorescence) |
| 00097494 | 2021-03-23 | MedNet GmbH | ACON Biotech (Hangzhou) Co., Ltd. | China | HN: Flowflex, Swiss Point of Care, Hughes AP: SARS-CoV-2 Antigen Rapid Test , SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) |
| 00097492 | 2020-10-06 | KTR Europe GmbH | COSMAXPHARMA | Korea, Rep. | HN: NOW Detect COVID-19 IgM/IgG Rapid Test AP: IVD-Reagenz zum Nachweis infektiöser Krankheitserreger SARS-CoV-2 |
| 00097195 | 2020-10-06 | KTR Europe GmbH | COSMAXPHARMA | Korea, Rep. | HN: iDetect SARS-CoV-2 Detection Kit |
| 00097510 | 2020-10-05 | Medical Technology Promedt Consulting GmbH | Asan Pharmaceutical Co., Ltd. | Korea, Rep. | HN: Product name: Novel Corona Virus Real Time PCR Detection Kit, Model name: Asan qPCR Test® COVID-19 |
| 00097485 | 2020-10-05 | mdi Europa GmbH | Formosa Biomedical Technology Corp. | Taiwan | AP: OTHER OTHER VIROLOGY RAPID TESTS |
| 00097152 | 2020-10-05 | B.R.A.H.M.S GmbH | Fisher Diagnostics, part of Thermo Fisher Scientific | Vereinigte Staaten von Amerika | HN: OmniPATH™ COVID-19 Total Antibody ELISA Test AP: OmniPATH™ COVID-19 Total Antibody ELISA Test |
| 00097446 | 2021-08-06 | Medical Technology Promedt Consulting GmbH | Absology Co., Ltd. | Korea, Rep. | HN: Absoludy COVID-19 IgM/IgG Combo; Absoludy COVID-19 Ag; Absoludy COVID-19 NAb |
| 00097475 | 2020-09-30 | Caretechion GmbH | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | China | AP: SARS-CoV-2 Virus Antigen Detection Kit (Immunofluorescence Chromatography) |
| 00097206 | 2020-10-01 | Shanghai International Holding Corporation GmbH (Europe) | Healgen Scientific Limited Liability Company | Vereinigte Staaten von Amerika | HN: Healgen AP: Influenza & COVID-19 Ag Combo Rapid Test Cassette (Swab) |
| 00097198 | 2020-10-01 | Shanghai International Holding Corporation GmbH (Europe) | Zhejiang Orient Gene Biotech Co.,Ltd | China | HN: Orient Gene AP: Influenza & COVID-19 Ag Combo Rapid Test Cassette (Swab) |
| 00097046 | 2020-09-30 | Caretechion GmbH | Nanjing Norman Biological Technology Co., Ltd. | China | AP: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) |
| 00096888 | 2020-10-01 | Shanghai International Holding Corporation GmbH (Europe) | Healgen Scientific Limited Liability Company | Vereinigte Staaten von Amerika | HN: Healgen AP: SARS-CoV-2 Detection Kit (Fluorescence PCR) |
| 00097458 | 2020-12-07 | ScheBo Biotech AG | Biohit Healthcare (Hefei) Co., Ltd. | China | AP: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) |
| 00097148 | 2020-09-25 | jtc-diagnostics | Add Bio Corporation | Korea, Rep. | HN: Add Start Taq DNA Polymerase AP: RT-PCR Kit |
| 00097412 | 2020-09-23 | Immundiagnostik AG | HN: MutaPlex® RespiraScreen 1 Real-Time-RT-PCR-Kit | ||
| 00097413 | 2020-09-22 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: SARS-CoV-2 RT-PCR Assay |
| 00097391 | 2020-09-22 | Roche Diagnostics GmbH | HN: PreciControl Anti-SARS-CoV-2 S | ||
| 00097389 | 2020-09-22 | Roche Diagnostics GmbH | HN: CalSet Anti-SARS-CoV-2 S | ||
| 00097388 | 2020-09-22 | Roche Diagnostics GmbH | HN: Elecsys Anti-SARS-CoV-2 S | ||
| 00097387 | 2020-09-22 | MedNet GmbH | NTBIO Diagnostics Inc. | Kanada | HN: NTBIO COVID-19 Antigen Test |
| 00097308 | 2020-09-22 | Shanghai International Holding Corporation GmbH (Europe) | Nantong Egens Biotechnology Co.,Ltd. | China | HN: Egens AP: COVID-19 Antigen Rapid Test Kit |
| 00097277 | 2021-06-30 | MedNet EC-REP GmbH | Beijing Beier Bioengineering Co., Ltd | China | HN: COVID-19 Antigen Rapid Test Kit (Sample Type: Nasopharyngeal swab and oropharyngeal swab), COVID-19 Antigen Rapid Test Kit-NS (Sample Type:Nasal swab and oropharyngeal swab), COVID-19 Antigen Rapid Test Kit-Saliva swab (Sample Type:Saliva swab), Mediport COVID-19 Antigen Rapid Test Kit (Ag Card) (Sample Type: Nasal swab and oropharyngeal swab) |
| 00096887 | 2020-09-22 | Shanghai International Holding Corporation GmbH (Europe) | Healgen Scientific Limited Liability Company | Vereinigte Staaten von Amerika | HN: Healgen AP: Coronavirus Ag Rapid Test Cassette (Swab) |
| 00096744 | 2020-09-22 | Institut Virion/Serion GmbH | HN: SERION ELISA agile SARS-CoV-2 IgA | ||
| 00096660 | 2020-09-22 | Institut Virion/Serion GmbH | HN: SERION ELISA agile SARS-CoV-2 IgG | ||
| 00097415 | 2020-12-17 | R-Biopharm AG | HN: RIDA®QUICK SARS-CoV-2 Antigen | ||
| 00097302 | 2020-09-17 | mdi Europa GmbH | Precision Biosensor Inc. | Korea, Rep. | AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION |
| 00097125 | 2020-09-17 | MEDsan GmbH | HN: MEDsan SARS-CoV-2 Antigen Rapid Test | ||
| 00097112 | 2020-09-17 | MedNet EC-REP GmbH | Beijing Beier Bioengineering Co., Ltd | China | HN: Detection kit for Novel Coronavirus(2019-nCoV) and other Coronavirus Nucleic Acids (Fluorescence RT-PCR) |
| 00097104 | 2020-09-17 | MedNet EC-REP GmbH | Beijing Beier Bioengineering Co., Ltd | China | HN: Novel Coronavirus 2019-nCoV Nucleic Acid Test Kit (Fluorescence RT-PCR) |
| 00096742 | 2020-09-16 | Roche Diagnostics, GmbH | Roche Molecular Systems, Inc. | Vereinigte Staaten von Amerika | HN: cobas® Liat® SARS-CoV-2 & Influenza A/B Script |
| 00096741 | 2020-09-16 | Roche Diagnostics, GmbH | Roche Molecular Systems, Inc. | Vereinigte Staaten von Amerika | HN: cobas® SARS-CoV-2 & Influenza A/B, cobas® SARS-CoV-2 & Influenza A/B Quality Control Kit |
| 00096637 | 2020-09-14 | Medical Device Safety Service GmbH | AccuDiagnostics LLC | Vereinigte Staaten von Amerika | HN: COVID-19 IgM/IgG Rapid Test Kit |
| 00097081 | 2020-09-09 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co., Ltd. | China | HN: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) AP: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) |
| 00097042 | 2020-09-10 | Caretechion GmbH | Shenzhen Dymind Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold) |
| 00096870 | 2020-09-09 | Devidia GmbH | HN: DEDIATEST 2019-nCoV IgG/IgM | ||
| 00096499 | 2020-09-10 | Caretechion GmbH | Genobio Pharmaceutical Co., Ltd. | China | HN: Virusee AP: COVID-19 IgG Antibody Detection Kit (CLIA) |
| 00096488 | 2020-09-10 | Caretechion GmbH | Genobio Pharmaceutical Co., Ltd. | China | HN: Virusee AP: COVID-19 IgM Antibody Detection Kit (CLIA) |
| 00095637 | 2020-09-08 | Luxus Lebenswelt GmbH | Shanghai Cagenbio Science Co., Ltd. | China | HN: COVID-19 IgG/IgM Rapid Test Kits (Later Flow Assay) AP: COVID-19 IgG/IgM Rapid Test Kits (Later Flow Assay) |
| 00095258 | 2020-09-08 | Luxus Lebenswelt GmbH | Shanghai Igenetec Diagnostics Co., Ltd. | China | HN: Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification on Microfluidic Chip) AP: Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification on Microfluidic Chip) |
| 00097305 | 2020-09-07 | Roche Diagnostics, GmbH | Roche Molecular Systems, Inc. | Vereinigte Staaten von Amerika | HN: cobas® SARS-CoV-2 & Influenza A/B, cobas® SARS-CoV-2 & Influenza A/B Control Kit |
| 00097036 | 2020-09-04 | mdi Europa GmbH | Precision Biosensor Inc. | Korea, Rep. | AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION |
| 00097154 | 2020-09-02 | Caretechion GmbH | Shenzhen Bioeasy Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 Ag FIA Rapid Test (Fluorescence Immunochromatographic Assay) |
| 00097127 | 2020-09-02 | Convergent Technologies GmbH & Co. KG | HN: Convergys® COVID-19 real-time PCR Kit | ||
| 00096935 | 2020-09-02 | Luxus Lebenswelt GmbH | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. | China | HN: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) AP: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) |
| 00096897 | 2020-09-02 | Caretechion GmbH | Guangzhou Decheng Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 Ag Rapid Test Kit (Immunochromatography) |
| 00097215 | 2020-08-31 | nal von minden GmbH | AP: COVID-19 Ag Test | ||
| 00097089 | 2020-08-31 | MIKROGEN GmbH | HN: recomLine SARS-CoV-2 IgG | ||
| 00096600 | 2020-08-28 | Adversis Pharma GmbH | HN: AProof SARS CoV-2 IgG ELISA | ||
| 00097092 | 2020-08-26 | Medical Device Safety Service GmbH | AI DE Diagnostic Co., Ltd | China | HN: SARS-CoV-2 Antibody (IgG/IgM) Test |
| 00097064 | 2021-01-05 | HUMAN Gesellschaft für Biochemica und Diagnostica mbH | PJSC "SPC "DIAPROPH-MED" | Ukraine | HN: AlphaBioScreen® SARS-CoV-2 Total Antibody |
| 00097063 | 2020-08-27 | HUMAN Gesellschaft für Biochemica und Diagnostica mbH | PJSC "SPC "DIAPROPH-MED" | Ukraine | HN: DIA-SARS-CoV-2 |
| 00097062 | 2020-08-27 | HUMAN Gesellschaft für Biochemica und Diagnostica mbH | PJSC "SPC "DIAPROPH-MED" | Ukraine | HN: Immupass-SARS-CoV-2-NP-IgA |
| 00097061 | 2020-08-27 | HUMAN Gesellschaft für Biochemica und Diagnostica mbH | PJSC "SPC "DIAPROPH-MED" | Ukraine | HN: DIA-SARS-CoV-2-NP-IgA |
| 00097060 | 2021-01-05 | HUMAN Gesellschaft für Biochemica und Diagnostica mbH | PJSC "SPC "DIAPROPH-MED" | Ukraine | HN: AlphaBioScreen® SARS-CoV-2-NP IgM |
| 00097059 | 2020-08-27 | HUMAN Gesellschaft für Biochemica und Diagnostica mbH | PJSC "SPC "DIAPROPH-MED" | Ukraine | HN: DIA-SARS-CoV-2-NP-IgM |
| 00097058 | 2021-01-05 | HUMAN Gesellschaft für Biochemica und Diagnostica mbH | PJSC "SPC "DIAPROPH-MED" | Ukraine | HN: AlphaBioScreen® SARS-CoV-2-NP IgG |
| 00096961 | 2020-08-27 | Curetis GmbH | HN: SARS-CoV-2 Kit with PULB | ||
| 00096427 | 2020-08-27 | HUMAN Gesellschaft für Biochemica und Diagnostica mbH | PJSC "SPC "DIAPROPH-MED" | Ukraine | HN: DIA-SARS-CoV-2-NP-IgG |
| 00096235 | 2020-08-27 | MedPath GmbH | Zhejiang Free Trade Zone R&S Biomedical Technology Co., Ltd. | China | HN: Coronavirus (SARS-CoV-2) Specific antibody IgG/IgM Test Kit (Colloidal gold) |
| 00096234 | 2020-08-27 | MedPath GmbH | Zhejiang Free Trade Zone R&S Biomedical Technology Co., Ltd. | China | HN: Coronavirus (SARS-COV-2) Nucleic Acid Test Kit (PCR Fluorescence) |
| 00096980 | 2020-08-25 | MEDsan GmbH | HN: MEDsan COVID-19 IgM/IgG Rapid Test | ||
| 00097109 | 2021-02-05 | Abbott Rapid Diagnostics Jena GmbH | HN: Panbio COVID-19 Ag Rapid Test Device | ||
| 00095641 | 2020-08-19 | Luxus Lebenswelt GmbH | GZ Vision Medicals instrument Co. LTD | China | HN: SARS-CoV-2 RT-PCR Assay AP: SARS-CoV-2 RT-PCR Assay |
| 00095335 | 2020-08-19 | Luxus Lebenswelt GmbH | Qingdao Jianma Gene Technology Co., Ltd. | China | HN: SARS-CoV-2 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method) AP: SARS-CoV-2 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method) |
| 00097037 | 2020-08-17 | jtc-diagnostics | Add Bio Corporation | Korea, Rep. | HN: Add Probe RT-PCR Kit AP: RT-PCR Kit |
| 00096948 | 2020-08-17 | MP Biomedicals Germany GmbH | MP Biomedicals Asia Pacific Pte. Ltd. | Singapur | HN: MP Diagnostics ASSURE SARS-CoV-2 IgG/IgM Rapid Test AP: COVID-19 |
| 00096179 | 2020-08-17 | MEXACARE GmbH | HN: YES or NO COVID-19 IgG/IgM | ||
| 00096173 | 2020-08-17 | MEXACARE GmbH | HN: QuickTestCorona COVID-19 IgG/IgM Schnelltest | ||
| 00096165 | 2021-08-04 | MEXACARE GmbH | HN: COVID-19 IgG/IgM Schnelltest (Vollblut/Serum/Plasma) | ||
| 00096273 | 2020-08-14 | MedPath GmbH | Shanxi Kangjianen Biotechnology Co.,Ltd. | China | HN: Diagnostic Kit for IgM/IgG 2in1 Antibody to 2019-nCoV (Colloidal Gold) |
| 00096256 | 2020-08-14 | SelfDiagnostics Deutschland GmbH | AP: SARS-CoV-2 IgM/IgG Antibody Assay Kit | ||
| 00096250 | 2020-08-14 | Immundiagnostik AG | HN: IDK® anti-SARS-CoV-2-IgG ELISA | ||
| 00097015 | 2020-09-25 | Intermundien-Lemon Europe GmbH | DIOGENE Co.,Ltd. | Korea, Rep. | HN: DLP™Q COVID19 Real Detection Kit, DLP™Q COVID19 RT-LAMP Kit |
| 00097012 | 2020-08-13 | Bosch Healthcare Solutions GmbH | HN: Vivalytic SARS-CoV-2 | ||
| 00097003 | 2020-08-12 | AmplexDiagnostics GmbH | HN: variplex SARS-CoV-2 direct | ||
| 00097002 | 2020-08-12 | AmplexDiagnostics GmbH | HN: variplex SARS-CoV-2 | ||
| 00096231 | 2020-06-30 | MedNet GmbH | Trentron Biomedical Ltd. | Taiwan | AP: VitaPCR SARS-CoV-2 Gen 2 Assay |
| 00097038 | 2021-06-25 | Medical Technology Promedt Consulting GmbH | Asan Pharmaceutical Co., Ltd. | Korea, Rep. | HN: Asan Easy Test® Influenza A/B; Product name: Rapid detection kit for influenza virus A, B and SARS-CoV-2 antigens (Model name: Asan Easy Test® Flu/COVID-19 Ag Combo); KNAX-SMART SARS-CoV-2, Influenza A&B Ag Combo (model name: KX-IDC1) |
| 00097035 | 2020-08-11 | KTR Europe GmbH | BioPOA Co., Ltd. | Korea, Rep. | HN: Rapid COVID COVID-19 PoaCheck ™ |
| 00096593 | 2020-08-27 | KTR Europe GmbH | BIOWITHUS Inc. | Korea, Rep. | HN: INFINA™ 2019_nCoV Realt-time RT-PCR kit AP: PCR Kit |
| 00096513 | 2020-08-11 | JaviTech e.K. | Genes Laboratories | Korea, Rep. | HN: NEXdia™ 2019-nCoV Detection Kit AP: Novel Coronavirus detection kit |
| 00096415 | 2020-08-11 | ABBOTT GmbH | Abbott Molecular Inc. | Vereinigte Staaten von Amerika | HN: Alinity m SARS-CoV-2 AMP Kit (9N78-90) |
| 00096414 | 2020-08-11 | ABBOTT GmbH | Abbott Moleclar Inc. | Vereinigte Staaten von Amerika | HN: Alinity m SARS-CoV-2 CRTL Kit (9N78-80) |
| 00096411 | 2020-08-11 | ABBOTT GmbH | Abbott Molecular Inc. | Vereinigte Staaten von Amerika | HN: Alinity m SARS-CoV-2 Application Specification File (9N78-01A) |
| 00097013 | 2021-05-14 | Medical Technology Promedt Consulting GmbH | SG Medical Inc. | Korea, Rep. | HN: R-FIND COVID-19 IgG ELISA; R-FIND COVID-19 IgG/M/A ELISA; R-FIND COVID-19 IgM ELISA; InstaView COVID-19 IgG/IgM; R-FIND Mycoplasma Pneumoniae IgG ELISA; R-FIND Mycoplasma pneumoniae IgM ELISA; InstaView COVID-19 Antigen; R-FIND SARS-CoV-2 Neutralizing Antibody ELISA |
| 00096569 | 2020-08-10 | MedPath GmbH | Epitope Biotechnology Co., Ltd. | China | HN: Novel Coronavirus COVID-19 IgM ELISA Kit |
| 00096568 | 2020-08-10 | MedPath GmbH | Epitope Biotechnology Co., Ltd. | China | HN: Novel Coronavirus COVID-19 IgG ELISA Kit |
| 00096916 | 2020-08-07 | AIDA GmbH | HN: SARS-CoV-2 NP IgM | ||
| 00096915 | 2020-08-07 | AIDA GmbH | HN: SARS-CoV-2 NP IgG | ||
| 00096914 | 2020-08-07 | AIDA GmbH | HN: SARS-CoV-2 NP IgA | ||
| 00097005 | 2021-02-25 | Medical Technology Promedt Consulting GmbH | ProteomeTech Inc. | Korea, Rep. | HN: Product name: GENEdania, Model name: GENEdania COVID-19 qRT-PCR; GENEdania SARS-CoV-2/FluA/FluB Fast qRT-PCR |
| 00096925 | 2020-10-02 | Medical Device Safety Service GmbH | ACON Laboratories, Inc. | Vereinigte Staaten von Amerika | HN: Promotor® AP: SARS-CoV-2 RT-PCR Test Kit |
| 00096913 | 2020-11-18 | Intermundien-Lemon Europe GmbH | WIZCHEM CO.,Ltd | Korea, Rep. | HN: Clinical Viral Transport Medium, Viral DNA/RNA Mini Prep Kit, COVICHEK SALIVA COLLECTION KIT |
| 00096871 | 2020-08-05 | MEDsan GmbH | HN: MEDsan COVID-19 IgM/IgG Rapid Test Hybrid | ||
| 00096718 | 2020-08-05 | JaviTech e.K. | PROTANBIO Inc. | Korea, Rep. | HN: PROTAN COVID-19 IgM/IgG AP: Novel Coronavirus Antibody Rapid Test |
| 00096926 | 2020-08-03 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clongene AP: SARS-CoV-2 Nucleic Acid RT-PCR Test Kit |
| 00096922 | 2021-04-16 | Medical Technology Promedt Consulting GmbH | General Biologicals Corporation | Taiwan | HN: GB SARS-CoV-2 Ab ELISA; GB SARS-CoV-2 IgG ELISA |
| 00096889 | 2021-02-25 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clongene AP: COVID-19 Antigen Rapid Test |
| 00096491 | 2020-08-03 | BioCheck GmbH | HN: Polycheck® Virus Infection Serology | ||
| 00096721 | 2020-07-29 | MedNet EC-REP GmbH | Beijing Beier Bioengineering Co., Ltd | China | HN: SARS-CoV-2 Total Ab Test Kit (ELISA) |
| 00096720 | 2020-07-29 | MedNet EC-REP GmbH | Beijing Beier Bioengineering Co., Ltd | China | HN: Anti-SARS-CoV-2 Antibody IgM Test Kit (ELISA) |
| 00096719 | 2020-07-29 | MedNet EC-REP GmbH | Beijing Beier Bioengineering Co., Ltd | China | HN: Anti-SARS-CoV-2 Antibody IgG Test Kit (ELISA) |
| 00096419 | 2020-07-30 | MedPath GmbH | Wuxi Shenrui Bio-pharmaceuticals Co., Ltd | China | HN: Coronavirus 2019-nCoV Nucleic Acid Detection Kit |
| 00095822 | 2020-07-29 | Luxus Lebenswelt GmbH | SUZHOU BACME BIOTECH CO., LTD. | China | HN: SARS-CoV-2 IgM/IgG detection kit (colloidal gold method) AP: SARS-CoV-2 IgM/IgG detection kit (colloidal gold method) |
| 00095778 | 2020-07-30 | Luxus Lebenswelt GmbH | VNT MEDICAL INTERNATIONAL JOINT STOCK COMPANY | Vietnam | HN: (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) AP: (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) |
| 00095724 | 2020-07-29 | Share Info Consultant Service LLC Repräsentanzbüro | Anhui Toneker Biotechnology Co., Ltd. | China | HN: Novel coronavirus (SARS-CoV-2) nucleic acid detection kit (PCR- fluorescence method) |
| 00095628 | 2020-07-30 | Luxus Lebenswelt GmbH | Tianjin Huaketai Biotechnology Co., Ltd. | China | HN: New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography) AP: New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography) |
| 00095438 | 2020-07-30 | Luxus Lebenswelt GmbH | JOYSBIO (Tianjin) Biotechnology Co., Ltd. | China | HN: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) AP: COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) |
| 00095245 | 2020-07-29 | Luxus Lebenswelt GmbH | SUZHOU BACME BIOTECH CO., LTD. | China | HN: Novel Coronavirus (SARS-CoV-2) RNA Real-Time Kit (PCR- fluorescence) AP: Novel Coronavirus (SARS-CoV-2) RNA Real-Time Kit (PCR- fluorescence) |
| 00096898 | 2020-07-27 | Medical Technology Promedt Consulting GmbH | Green Cross Medical Science Corporation | Korea, Rep. | HN: GENEDIA W COVID-19 Colorimetric LAMP premix Kit |
| 00096648 | 2020-10-06 | Medical Device Safety Service GmbH | NanoBioLife Inc. | Korea, Rep. | HN: Nano-KGIC™ COVID-19 IgM/IgG Kit |
| 00096638 | 2020-07-27 | Medical Device Safety Service GmbH | W.H.P.M. Inc. | Vereinigte Staaten von Amerika | HN: COVISURE™ COVID-19 IgM/IgG Rapid Test |
| 00096386 | 2020-07-24 | Luxus Lebenswelt GmbH | Shanghai IVEN Medical Technology Co.,Ltd | China | HN: COVID-19 rapid test kit( PCR) AP: COVID-19 rapid test kit( PCR) |
| 00096650 | 2020-07-22 | Europecert UG (haftungsbeschränkt) | LP Diagnostic LLC | Ukraine | HN: VLM (Viral Lysis Medium) AP: Abstrich- und Transportsystem |
| 00096623 | 2020-07-22 | EUROIMMUN Medizinische Labordiagnostika AG | AP: Anti-SARS-CoV-2-NCP-ELISA | ||
| 00096786 | 2020-08-24 | Medical Technology Promedt Consulting GmbH | Sanigen Co., Ltd. | Korea, Rep. | HN: Genelix™ COVID-19 Real-time PCR Kit; Genelix™ Viral DNA/RNA Extraction Kit [Column type] |
| 00096716 | 2020-07-21 | gerbion GmbH & Co. KG | HN: respiraScreen 1 real time RT-PCR Kit AP: G01129 |
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| 00096635 | 2020-07-21 | LIONEX GmbH | HN: COVELISA®COVID-19 IgM ELISA | ||
| 00096634 | 2020-07-20 | Cytecs GmbH | HN: SARS-CoV-2 RT-PCR | ||
| 00096717 | 2020-07-17 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: SARS-CoV-2 S-RBD lgG (CLIA) |
| 00096705 | 2020-07-16 | Medical Technology Promedt Consulting GmbH | AMSBIO Co., Ltd. | Korea, Rep. | HN: Product name: COVID-19 RT-qPCR Detection Kit, Trade name: A+ CheQ COVID-19 High-Speed RT-qPCR Detection Kit |
| 00096611 | 2020-07-16 | Aesku.Diagnostics GmbH & Co. KG | HN: AESKULISA SARS-CoV-2 NP IgM | ||
| 00096574 | 2020-07-15 | Medical Device Safety Service GmbH | DiaCarta, Inc. | Vereinigte Staaten von Amerika | HN: QuantiVirus™ Anti-SARS-CoV-2 IgG Test |
| 00096445 | 2020-07-16 | BIORON GmbH | AO Vector-Best | Russische Föderation | HN: SARS-CoV-2-IgG-EIA-BEST, REF D-5501 |
| 00096443 | 2020-07-16 | BIORON GmbH | AO Vector-Best | Russische Föderation | HN: SARS-CoV-2-IgM-EIA-BEST, REF D-5502 |
| 00096418 | 2020-06-25 | MedPath GmbH | Sanming Bofeng Biotechnology Co.,Ltd | China | HN: Novel Coronavirus (SARS-CoV-2) Antibody Kit (Colloidal Gold) |
| 00096091 | 2020-07-16 | Caretechion GmbH | Sophonix Co., Ltd. | China | HN: Severe Acute Respiratory Coronavirus 2 S1 Protein test kit (Magnetic particle chemiluminescence method) |
| 00095879 | 2020-07-15 | MedPath GmbH | Sanming Bofeng Biotechnology Co.,Ltd | China | HN: Novel Coronavirus (SARS-CoV-2) Antibody IgM/IgG Kit (Colloidal Gold) |
| 00096530 | 2020-07-14 | NIC GmbH | Shandong ThinkLab Biotechnology Co., Ltd | China | HN: 2019-nCoV IgM&IgG antibody Test Kit (Colloidal-gold Assay) AP: 2019-nCoV IgM&IgG antibody Test Kit (Colloidal-gold Assay) |
| 00096519 | 2020-07-14 | MedNet EC-REP GmbH | Joy HealthCare Industry Co. Ltd. | Jordanien | AP: COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) |
| 00096455 | 2020-07-14 | MIKROGEN GmbH | HN: recomWell SARS-CoV-2 IgA | ||
| 00096304 | 2020-07-01 | MedPath GmbH | Shijiazhuang Lumitest Biotechnology Co.,Ltd | China | HN: COVID-19 IgG/IgM Rapid Test Kit |
| 00096581 | 2020-07-10 | Vela Diagnostics Germany GmbH | Vela Operations Singapore Pte Ltd | Singapur | HN: ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 |
| 00096563 | 2020-07-10 | ScheBo Biotech AG | HN: ScheBo SARS-CoV-2 Antigen ELISA | ||
| 00096524 | 2020-07-10 | Bioron Diagnostics GmbH | HN: RealLine SARS CoV-2 lyo (Str-format) VBD5580 | ||
| 00096639 | 2020-07-09 | jtc-diagnostics | Pishtaz Teb Zaman Diagnostics Co. | Iran, Islam. Rep. | HN: SARS-CoV-2 IgM Capture ELISA AP: IgM ELISA |
| 00096596 | 2020-07-08 | DiaMex GmbH | HN: Optitrol COVID-19 M AP: Optitrol COVID-19 M |
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| 00096595 | 2020-07-08 | DiaMex GmbH | HN: Optitrol COVID-19 G AP: Optitrol COVID-19 G |
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| 00096169 | 2020-07-08 | BIORON GmbH | AO Vector-Best | Russische Föderation | HN: RealBest RNA SARS-CoV-2 , REF D-5580 |
| 00095638 | 2020-07-09 | Luxus Lebenswelt GmbH | Shanghai Cagenbio Science Co., Ltd. | China | HN: COVID -19Nucleic Aicd Kits (Fluorescence RT-PCR) AP: COVID -19Nucleic Aicd Kits (Fluorescence RT-PCR) |
| 00095543 | 2020-07-09 | Luxus Lebenswelt GmbH | H&Z Life Science Co. LTD | China | HN: Anti-COVID-19 virus IgM/IgG test kit (lateral flow assay) AP: Anti-COVID-19 virus IgM/IgG test kit (lateral flow assay) |
| 00095469 | 2020-07-09 | Luxus Lebenswelt GmbH | BIONEOVAN Co., LTD | China | HN: Diagnostic Kit for IgG Antibody to 2019-nCoV (Colloidal Gold) AP: Diagnostic Kit for IgG Antibody to 2019-nCoV (Colloidal Gold) |
| 00095468 | 2020-07-09 | Luxus Lebenswelt GmbH | BIONEOVAN Co., LTD | China | HN: Diagnostic Kit for IgM Antibody to 2019-nCoV (Colloidal Gold) AP: Diagnostic Kit for IgM Antibody to 2019-nCoV (Colloidal Gold) |
| 00095467 | 2020-07-09 | Luxus Lebenswelt GmbH | BIONEOVAN Co., LTD | China | HN: Diagnostic Kit for IgM/IgG 2in1 Antibody to 2019-nCoV (Colloidal Gold) AP: Diagnostic Kit for IgM/IgG 2in1 Antibody to 2019-nCoV (Colloidal Gold) |
| 00095329 | 2020-07-09 | Luxus Lebenswelt GmbH | Hemosmart Medical Technology Limited | China | HN: New coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Fluorescence PCR) AP: New coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Fluorescence PCR) |
| 00096534 | 2020-07-07 | Caretechion GmbH | Guangzhou Decheng Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 IgG&IgM Antibody Rapid Test Kit (Colloidal Gold) |
| 00096532 | 2020-07-07 | Caretechion GmbH | Guangzhou Decheng Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 Ag Rapid Test Kit (Fluorescence Immunochromatographic) |
| 00096444 | 2020-07-07 | Caretechion GmbH | Guangzhou Decheng Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 IgG&IgM Antibody Rapid Test Kit |
| 00096442 | 2020-07-07 | Caretechion GmbH | Guangzhou Decheng Biotechnology Co., Ltd. | China | AP: SARS-CoV-2 Antibody Rapid Test Kit |
| 00096086 | 2020-07-07 | MedPath GmbH | Shanghai Personalbio Technology Co.,Ltd. | China | HN: SARS-CoV-2 nucleic acid detection kit (Quantitative fluorescence PCR) |
| 00095978 | 2020-07-07 | Caretechion GmbH | Sophonix Co., Ltd. | China | HN: SARS-CoV-2 IgM antibody test kit |
| 00095976 | 2020-07-07 | Caretechion GmbH | Sophonix Co., Ltd. | China | HN: SARS-CoV-2 IgG antibody test kit |
| 00095880 | 2020-07-07 | MedPath GmbH | Abioquant Bio-medical Technology Co., Ltd. | China | HN: COVID-19 IgM/IgG Rapid Test Kit(Colloidal Gold Immunochromatography) |
| 00095878 | 2020-07-07 | MedPath GmbH | Bioda Diagnostics (Wuhan) Co., Ltd | China | HN: Novel Coronavirus(COVID-19) Antibody IgM/IgG Test (Colloidal Gold) |
| 00095827 | 2020-07-07 | DiaMex GmbH | HN: Optitrol NAT SARS-CoV-2 AP: Kontrolle für SARS-CoV-2 |
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| 00095651 | 2020-07-07 | Luxus Lebenswelt GmbH | Shanxi Nadexi Biological Technology Co., Ltd. | China | HN: SARS-COV-2 IgM/IgG Antibody Test Kit(Colloidal Gold Immunochromatography) AP: SARS-COV-2 IgM/IgG Antibody Test Kit(Colloidal Gold Immunochromatography) |
| 00095608 | 2020-07-07 | Luxus Lebenswelt GmbH | Ningbo Institute of Life and Health Industry, University of Chinese Academy of Sciences | China | HN: SARS-CoV-2 IgM TEST KIT (Chemiluminescent immunoassay) AP: SARS-CoV-2 IgM TEST KIT (Chemiluminescent immunoassay) |
| 00095607 | 2020-07-07 | Luxus Lebenswelt GmbH | Ningbo Institute of Life and Health Industry, University of Chinese Academy of Sciences | China | HN: SARS-CoV-2 IgG TEST KIT (Chemiluminescent immunoassay) AP: SARS-CoV-2 IgG TEST KIT (Chemiluminescent immunoassay) |
| 00095606 | 2020-07-07 | Luxus Lebenswelt GmbH | Ningbo Institute of Life and Health Industry, University of Chinese Academy of Sciences | China | HN: SARS-CoV-2 ANTIBODY TEST KIT (Chemiluminescent immunoassay) AP: SARS-CoV-2 ANTIBODY TEST KIT (Chemiluminescent immunoassay) |
| 00095605 | 2020-07-07 | Luxus Lebenswelt GmbH | Ningbo Ziyuan Medical Device Co.Ltd | China | HN: Accufast-8 SARS-CoV-2 IgM Test Kit (Rapid Chemiluminescent immunoassay) AP: Accufast-8 SARS-CoV-2 IgM Test Kit (Rapid Chemiluminescent immunoassay) |
| 00095604 | 2020-07-07 | Luxus Lebenswelt GmbH | Ningbo Ziyuan Medical Device Co.Ltd | China | HN: Accufast-8 SARS-CoV-2 IgG Test Kit (Rapid Chemiluminescent immunoassay) AP: Accufast-8 SARS-CoV-2 IgG Test Kit (Rapid Chemiluminescent immunoassay) |
| 00095603 | 2020-07-07 | Luxus Lebenswelt GmbH | Ningbo Ziyuan Medical Device Co.Ltd | China | HN: Accufast-8 SARS-CoV-2 Antibody Test Kit (Rapid Chemiluminescent immunoassay) AP: Accufast-8 SARS-CoV-2 Antibody Test Kit (Rapid Chemiluminescent immunoassay) |
| 00095503 | 2020-07-07 | Luxus Lebenswelt GmbH | Zhengzhou Fortune Bioscience Co., Ltd | China | HN: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) AP: COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) |
| 00095502 | 2020-07-07 | Luxus Lebenswelt GmbH | Zhengzhou Fortune Bioscience Co., Ltd | China | HN: COVID-19 IgM Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) AP: COVID-19 IgM Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) |
| 00096636 | 2021-09-17 | Medical Technology Promedt Consulting GmbH | ProteomeTech Inc. | Korea, Rep. | HN: Product name: KOVIcheck COVID-19 IgG/ IgM, Model name: KOVIcheck COVID-19 IgG/IgM; KOVIcheck-F COVID-19 IgG/IgM |
| 00096632 | 2021-04-27 | Medical Technology Promedt Consulting GmbH | MiCoBioMed Co., Ltd. | Korea, Rep. | HN: Brand name: VERI-Q COVID-19 IgG/IgM Rapid Test; Model name: MIS-COV-01; Brand name: VERI-Q COVID-19 Ag Rapid Test, Model name: MIS-COV-02, MIS-COV-02-01; Brand name: Ab COVID-19 Biokit IgG/IgM Model name: MIS-COV-01-AB; Brand name: COVID-19 Biokit IgG/IgM, Model name: MIS-COV-01-HP |
| 00096487 | 2020-07-06 | Share Info Consultant Service LLC Repräsentanzbüro | Suzhou Geneworks Technologies Co.,Ltd | China | HN: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR) AP: 50 Tests/Kit |
| 00096254 | 2020-07-06 | Share Info Consultant Service LLC Repräsentanzbüro | Sichuan Mass Spectrometry Biotechnology Co., Ltd | China | HN: Fluorescent PCR Probe Detection Kit for SARS-CoV-2 |
| 00096252 | 2020-07-06 | Share Info Consultant Service LLC Repräsentanzbüro | Sichuan Mass Spectrometry Biotechnology Co., Ltd | China | HN: Novel Coronavirus (2019-nCov) IgM/IgG Antibodies Detection Kit (Latex Chromatography) |
| 00095742 | 2020-07-03 | Luxus Lebenswelt GmbH | Shanghai Igenetec Diagnostics Co., Ltd. | China | HN: Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence PCR) AP: Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence PCR) |
| 00095626 | 2020-07-03 | Luxus Lebenswelt GmbH | Shanghai Igenetec Diagnostics Co., Ltd. | China | HN: SARS-CoV-2 IgM/IgG Ab Diagnostic Test kit (Colloidal Gold-Based) AP: SARS-CoV-2 IgM/IgG Ab Diagnostic Test kit (Colloidal Gold-Based) |
| 00095590 | 2020-07-03 | Luxus Lebenswelt GmbH | Bozhou Xinjiankang Science and Technology Co., Ltd | China | HN: COVID-19 Rapid Test Cassette AP: COVID-19 Rapid Test Cassette |
| 00096594 | 2020-07-01 | MedNet EC-REP GmbH | Eternal Materials Co., Ltd. | Taiwan | HN: COVIDual COVID 19 IgM/IgG Rapid Test AP: COVID 19 IgM/IgG Rapid Test |
| 00096495 | 2020-07-02 | mdi Europa GmbH | Excelsior-Biosystem Inc. | Taiwan | AP: OTHER OTHER VIROLOGY RAPID TESTS |
| 00096330 | 2020-07-02 | Caretechion GmbH | Guilin Zhonghui Technology Co., Ltd. | China | AP: COVID-19 IgM TEST(Colloidal Gold Immuno-chromatography) |
| 00096329 | 2020-07-02 | Caretechion GmbH | Guilin Zhonghui Technology Co., Ltd. | China | AP: COVID-19 IgG TEST(Colloidal Gold Immuno-chromatography) |
| 00096312 | 2020-07-02 | Aesku.Diagnostics GmbH & Co. KG | HN: AESKULISA SARS-CoV-2 NP IgG | ||
| 00096311 | 2020-07-02 | Aesku.Diagnostics GmbH & Co. KG | HN: AESKULISA SARS-CoV-2 NP IgA | ||
| 00096230 | 2020-07-01 | MedPath GmbH | Suzhou Soochow University Saier ImmunoBiotech Co., Ltd. | China | HN: SARS-CoV-2 IgG/IgM Rapid Test Cassette (Colloidal Gold) |
| 00095938 | 2020-07-02 | Caretechion GmbH | Genosor Medical Science&Technology Inc. | China | HN: SARS-CoV-2 Isothermal Amplification Detection Kit |
| 00095664 | 2020-07-02 | Caretechion GmbH | Hunan Hoomya Gene Technology Co.,Ltd. | China | AP: SARS-CoV-2IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) |
| 00095526 | 2020-07-02 | Caretechion GmbH | Shenzhen Aodong Inspection & Testing Technology Co., Ltd. | China | AP: Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method) |
| 00095399 | 2020-07-02 | MedPath GmbH | Hunan Runmei Gene Technology Co., Ltd. | China | HN: New Coronavirus COVID-19 Antibody Detection Kit (Colloidal Gold) |
| 00095285 | 2020-07-02 | MedPath GmbH | Hunan Runmei Gene Technology Co., Ltd. | China | HN: New Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent RT-PCR Method) |
| 00096591 | 2020-06-30 | Medical Technology Promedt Consulting GmbH | BIOMETRIX TECHNOLOGY INC. | Korea, Rep. | HN: COVID19+ 9G test™ |
| 00096465 | 2020-06-30 | MedNet EC-REP GmbH | Syntron Bioresearch, Inc. | Vereinigte Staaten von Amerika | HN: QuikPac II COVID-19 IgG/IgM Rapid Test AP: Novel Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test |
| 00096232 | 2020-06-30 | MedNet GmbH | Trentron Biomedical Ltd. | Taiwan | HN: VitaPCR AP: VitaPCR SARS-CoV-2 Gen 2 External Control Set |
| 00096083 | 2020-06-30 | Bioron Diagnostics GmbH | HN: RealLine SARS-CoV-2 (A-Format BI1019-96; RealLine SARS-CoV-2 (B-format) BI1020-96 | ||
| 00096576 | 2020-11-30 | Medical Technology Promedt Consulting GmbH | NanoEnTek Inc. | Korea, Rep. | HN: FREND™ FLU A&B; FREND™ COVID-19 Ag+FLU A&B AP: Qualitative assay for influenza A and/or B |
| 00096547 | 2020-06-29 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | AP: SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) |
| 00096438 | 2020-06-29 | mdi Europa GmbH | Abnova (Taiwan) Corporation | Taiwan | AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION |
| 00095881 | 2020-06-26 | MedPath GmbH | Wuxi Shenrui Bio-pharmaceuticals Co., Ltd | China | HN: Covflu-SR, Coronavirus 2019-nCoV and Influenza Virus A/B Nucleic Acid Detection Kit |
| 00096562 | 2020-06-25 | Medical Technology Promedt Consulting GmbH | CALTH Inc. | Korea, Rep. | HN: DxReal COVID-19 Detection Kit |
| 00096541 | 2020-06-25 | MedNet EC-REP GmbH | Beijing Beier Bioengineering Co., Ltd | China | HN: 2019-New Coronavirus Antibody Rapid Test Cassette (Colloidal gold) |
| 00095696 | 2020-06-25 | MedPath GmbH | Tianjin GensKey Medical Technology Co., Ltd. | China | HN: GensKey SARS-CoV-2 Sequencing Assay |
| 00095666 | 2020-06-25 | MedPath GmbH | Tianjin GensKey Medical Technology Co., Ltd. | China | HN: GensKey SARS-CoV-2 RT-PCR Kit |
| 00096458 | 2020-06-23 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | HN: Mindray AP: SARS-CoV-2 IgM Positive Control |
| 00096457 | 2020-06-23 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | HN: Mindray AP: SARS-CoV-2 IgM/IgG Negative Control |
| 00096456 | 2020-06-29 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | HN: Mindray AP: SARS-CoV-2 IgG Positive Control |
| 00095854 | 2020-06-23 | MedNet EC-REP GmbH | Guangzhou SupBio Bio-Technology and Science Co., Ltd | China | HN: SARS-CoV-2 (ORF1ab/N) Nucleic Acid Detection Kit (PCR-Fluorescent Probing) |
| 00095491 | 2020-06-23 | MedPath GmbH | Qingyuan Biotech (Shenzhen) Co. Ltd. | China | HN: SARS-CoV-2 (COVID-19) Antibody Rapid Detection Kit |
| 00095472 | 2020-06-23 | Luxus Lebenswelt GmbH | Zhejiang Jiankang BIOTECH CO., LTD. | China | HN: SARS-CoV-2(COVID-19)IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) AP: SARS-CoV-2(COVID-19)IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) |
| 00095377 | 2020-06-23 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co.,Ltd. | China | HN: 2019-nCoV-IgM Assay Reagent Kit (CMIA) AP: 2019-nCoV-IgM Assay Reagent Kit (CMIA) |
| 00095376 | 2020-06-23 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co.,Ltd. | China | HN: 2019-nCoV-IgG Assay Reagent Kit (CMIA) AP: 2019-nCoV-IgG Assay Reagent Kit (CMIA) |
| 00095374 | 2020-06-23 | Luxus Lebenswelt GmbH | Hangzhou Realy Tech Co.,Ltd. | China | HN: 2019-nCOV IgG/IgM Rapid Test Device(Whole blood/Serum/Plasma) AP: 2019-nCOV IgG/IgM Rapid Test Device(Whole blood/Serum/Plasma) |
| 00096514 | 2020-06-22 | Medical Technology Promedt Consulting GmbH | SD Biosensor, Inc. | Korea, Rep. | HN: STANDARD™ Q COVID-19 IgM/IgG Combo Test Supplement Buffer; STANDARD™ Q COVID-19 IgM/IgG Duo Test Supplement Buffer |
| 00096512 | 2020-06-19 | Intermundien-Lemon Europe GmbH | FA INC | Korea, Rep. | HN: FTM (FA Transport Medium) / SDB VTM(SD Viral Transport Medium) |
| 00096428 | 2020-06-19 | DRG Instruments GmbH | HN: SARS-CoV-2 Antibody | ||
| 00096476 | 2020-06-18 | Medical Technology Promedt Consulting GmbH | Green Cross Medical Science Corporation | Korea, Rep. | HN: GENEDIA W COVID-19 Real-Time RT-PCR Kit |
| 00096337 | 2020-09-09 | mdi Europa GmbH | Precision Biosensor Inc. | Korea, Rep. | AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION |
| 00096271 | 2020-06-17 | Genome Identification Diagnostics GmbH | HN: SARS-CoV-2 Detection Kit AP: Nachweis von SARS-CoV-2 RNA |
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| 00096107 | 2020-06-17 | Luxus Lebenswelt GmbH | Changzhou GenMagBio Biotechnology Co., Ltd. | China | HN: Real-Time RT-PCR Test Kit of SARS-CoV-2 Coronavirus AP: Real-Time RT-PCR Test Kit of SARS-CoV-2 Coronavirus |
| 00096079 | 2020-06-17 | mediagnost Gesellschaft für Forschung und Herstellung von Diagnostika GmbH | HN: E111-IVD AP: Anti-SARS-CoV-2 ELISA |
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| 00095921 | 2020-06-17 | Shanghai International Holding Corporation GmbH (Europe) | Dongguan Bosh Biotechnologies, Ltd. | China | HN: Bosh AP: COVID-19 IgM & IgG Rapid Test |
| 00095796 | 2020-06-17 | Shanghai International Holding Corporation GmbH (Europe) | Polymer Technology Systems, Inc. | Vereinigte Staaten von Amerika | HN: Polymer AP: SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method) |
| 00095675 | 2020-06-17 | Shanghai International Holding Corporation GmbH (Europe) | Guangzhou Leide Biosciences Co., LTD. | China | HN: Leide AP: SARS-CoV-2 IgM Antibody Diagnostic Kit (ELISA) |
| 00095674 | 2020-06-17 | Shanghai International Holding Corporation GmbH (Europe) | Guangzhou Leide Biosciences Co., LTD | China | HN: Leide AP: SARS-CoV-2 IgG Antibody Diagnostic Kit (ELISA) |
| 00096259 | 2020-06-16 | Convergent Technologies GmbH & Co. KG | HN: Convergys® POC RT-PCR COVID-19 Detection Kit | ||
| 00096118 | 2020-06-15 | MedPath GmbH | Shanghai Bionaire Biotech Co., Ltd. | China | HN: Novel Coronavirus (COVID-19) Antibody (IgM/IgG) Test |
| 00096475 | 2021-01-25 | Medical Technology Promedt Consulting GmbH | Absology Co., Ltd. | Korea, Rep. | HN: Absoludy COVID-19 IgM/IgG Rapid; INIST COVID-19 lgM/lgG Rapid; Absoludy COVID-19 Ag RAPID; INIST COVID-19 Ag Rapid |
| 00096355 | 2020-06-12 | MedNet GmbH | ACON Biotech (Hangzhou) Co., Ltd. | China | HN: Promotor AP: SARS-COV-2 RT-PCR Test Kit |
| 00095893 | 2020-06-12 | Jungbrunnen - Fountain of Youth GmbH | HN: VHC COVID-19 IgG/IgM AP: Schnelltest zur Bestimmung von anti-SARS-CoV-2 IgG- und IgM-Antikörpern |
||
| 00096425 | 2020-07-02 | Astra Biotech GmbH | HN: SARS-CoV-2 Triplex PCR kit_Form S, SARS-CoV-2 Triplex PCR kit_Form T,SARS-CoV-2 Triplex PCR kit_Form F | ||
| 00096417 | 2020-06-11 | LIONEX GmbH | HN: LD COVID-19 IgM Rapid Test / LD COVID-19 IgM Schnelltest | ||
| 00096416 | 2020-06-11 | LIONEX GmbH | HN: LD COVID-19 IgG Rapid Test / LD COVID-19 IgG Schnelltest | ||
| 00096410 | 2020-06-10 | Pharma-Peter GmbH | HN: Covid-19 Canea Schnelltest AP: Covid-19 IgM/IgG Ab Schnelltest |
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| 00095244 | 2020-06-10 | mölab GmbH | HN: mö-screen 2019-NCOV Corona Virus Test | ||
| 00096359 | 2020-06-09 | Luxus Lebenswelt GmbH | Ring Biotechnology Co Ltd | China | HN: COVID-19 IgM/IgG Rapid Test Kit AP: COVID-19 IgM/IgG Rapid Test Kit |
| 00096213 | 2020-08-21 | TIB Molbiol Syntheselabor GmbH | HN: LightMix® SarbecoV E-gene EAV AP: 40-0776-96 (40-0776-10) |
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| 00096076 | 2020-06-09 | Caretechion GmbH | MEIZHOU CORNLEY® HI-TECH CO.,LTD | China | HN: COVID-19 IgG/IgM Detection Kit(Colloidal Gold) |
| 00096066 | 2020-05-28 | R-Biopharm AG | HN: RIDA®GENE SARS-CoV-2 | ||
| 00095695 | 2020-06-09 | I-Import UG (haftungsbeschränkt) | Jiangxi Yeli Medical Apparatus Co., Ltd. | China | HN: YELI MEDICAL AP: Detection Kit for 2019-nCoV Antibody |
| 00095694 | 2020-06-09 | I-Import UG (haftungsbeschränkt) | Jiangxi Yeli Medical Apparatus Co., Ltd. | China | HN: YELI MEDICAL AP: Detection Kit for 2019-nCoV Antibody |
| 00095693 | 2020-06-09 | I-Import UG (haftungsbeschränkt) | Jiangxi Yeli Medical Apparatus Co., Ltd. | China | HN: YELI MEDICAL AP: Detection Kit for Novel Coronavirus 2019-nCoV RNA |
| 00095615 | 2020-06-09 | Luxus Lebenswelt GmbH | Beijing Savant Biotechnology Co., Ltd. | China | HN: New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography) AP: New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography) |
| 00095556 | 2020-06-09 | Caretechion GmbH | Xi'an Bioreal-Coming BioMed Center Co., Ltd. | China | AP: COIVD-19 Nucleic Acid Detection Kit (Fluorescence PCR Method) |
| 00095524 | 2020-06-09 | Caretechion GmbH | Wuxi Techstar Technology Co.,Ltd. | China | AP: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification Fluorescence Method) |
| 00095465 | 2020-06-09 | Luxus Lebenswelt GmbH | Zhuhai Keyu Biological Engineering Co.,LTD. | China | HN: SARS-CoV-2 IgG/IgM Rapid Test Kit ( Immunochromatography) AP: SARS-CoV-2 IgG/IgM Rapid Test Kit ( Immunochromatography) |
| 00096446 | 2020-06-08 | Medical Technology Promedt Consulting GmbH | Humedix Co., Ltd. | Korea, Rep. | HN: Accurate Rapid COVID-19 IgM/IgG Combo Test |
| 00096440 | 2020-06-08 | Medical Technology Promedt Consulting GmbH | BioNote, Inc. | Korea, Rep. | HN: NowCheck COVID-19 Ag Control; NowCheck COVID-19 IgM/IgG Control |
| 00096437 | 2020-11-24 | Medical Technology Promedt Consulting GmbH | BioNote, Inc. | Korea, Rep. | HN: NowCheck COVID-19 Ag Test; NowCheck COVID-19 IgM/IgG Test |
| 00096354 | 2020-06-08 | AB Diagnostic Systems GmbH | HN: abia SARS-CoV-2 IgG/IgM | ||
| 00096353 | 2020-06-08 | AB Diagnostic Systems GmbH | RPC Diagnostic Systems Ltd. | Russische Föderation | HN: DS-EIA-ANTI-SARS-CoV-2 |
| 00096349 | 2020-06-08 | NanoRepro AG | InTec PRODUCTS, INC. | China | HN: SARS-CoV-2 Antikörper-Schnelltest (IgM/IgG) |
| 00096047 | 2021-06-30 | Shanghai International Holding Corporation GmbH (Europe) | Suzhou Hokapi Biomedical Engineering Co., Ltd. | China | HN: Hokapi AP: HOKAPI™ SARS-CoV-2 IgM |
| 00096046 | 2021-06-30 | Shanghai International Holding Corporation GmbH (Europe) | Suzhou Hokapi Biomedical Engineering Co., Ltd. | China | HN: Hokapi AP: HOKAPI™ SARS-CoV-2 IgG |
| 00095578 | 2020-06-08 | Shanghai International Holding Corporation GmbH (Europe) | Sichuan Xincheng Biological Co., Ltd. | China | HN: Xincheng AP: SARS-Cov-2 IgG/M Antibody Assay Kit by Colloidal Gold Method |
| 00096422 | 2020-06-05 | Medical Technology Promedt Consulting GmbH | ADtech Co, Ltd. | Korea, Rep. | HN: ADTech COVID-19 IgM/IgG RAPID KIT; DNALINK FIND COVID19 AP: Rapid Test Kit for COVID-19 IgM/IgG |
| 00096401 | 2021-06-11 | Medical Technology Promedt Consulting GmbH | OPTI Medical Systems, Inc. | Vereinigte Staaten von Amerika | HN: OPTI SARS-CoV-2 RT-PCR Test; OPTI DNA/RNA Magnetic Bead Extraction Kit; OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test; OPTI Rapid Lysis Buffer Kit |
| 00095682 | 2020-06-04 | Share Info Consultant Service LLC Repräsentanzbüro | Redpharm (Changchun) Biotechnology Co.,Ltd | China | HN: Biochip Analyzer |
| 00095681 | 2020-06-04 | Share Info Consultant Service LLC Repräsentanzbüro | Redpharm (Changchun) Biotechnology Co.,Ltd | China | HN: SARS-CoV-2 IgG/IgM Antibody Test Strip (Colloidal gold method) |
| 00095679 | 2020-06-04 | Share Info Consultant Service LLC Repräsentanzbüro | Redpharm (Changchun) Biotechnology Co.,Ltd | China | HN: Test Cartridge for SARS-CoV-2 IgG/IgM Antibody (Immune electrochemical method) |
| 00095635 | 2020-06-03 | Luxus Lebenswelt GmbH | Jiangsu Simcere Medical Device Co. Ltd | China | HN: SARS-CoV-2 Nucleic Acid Detection Kit ( Fluorescence Qualitative RT-PCR) AP: SARS-CoV-2 Nucleic Acid Detection Kit ( Fluorescence Qualitative RT-PCR) |
| 00095634 | 2020-06-03 | Luxus Lebenswelt GmbH | Jiangsu Simcere Medical Device Co. Ltd | China | HN: SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit ( Colloidal-Gold Immunochromatographic Assay) AP: SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit ( Colloidal-Gold Immunochromatographic Assay) |
| 00096399 | 2021-08-18 | Medical Technology Promedt Consulting GmbH | Wizbiosolutions Inc. | Korea, Rep. | HN: WizDx™ COVID-19 CrystalMix PCR Kit; WizDx™ COVID-19 Real-time PCR Kit; WizDx™ COVID-19 CrystalMix™ Multi PCR Kit |
| 00096249 | 2020-06-02 | MedNet GmbH | ACON Biotech (Hangzhou) Co., Ltd. | China | HN: Foresight AP: SARS-COV-2 IgM EIA Test Kit |
| 00096248 | 2020-06-02 | MedNet GmbH | ACON Biotech (Hangzhou) Co., Ltd. | China | HN: Foresight AP: SARS-COV-2 IgG EIA Test Kit |
| 00096389 | 2021-03-05 | Medical Technology Promedt Consulting GmbH | PRIME4DIA Co., Ltd. | Korea, Rep. | HN: P4DETECT COVID-19 IgM/IgG; INNOGEN-P COVID-19 IgM/IgG Rapid Test; P4DETECT COVID-19 Ag; P4DETECT COVID-19 Ag/Flu |
| 00096377 | 2020-05-29 | Medical Technology Promedt Consulting GmbH | NanoEnTek Inc. | Korea, Rep. | HN: En-swer™ COVID-19 RT-PCR Kit AP: Qualitative assay for severe acute respiratory syndrome coronavirus-2 |
| 00096371 | 2021-04-23 | MedNet GmbH | ACRO BIOTECH Inc. | Vereinigte Staaten von Amerika | AP: 2019-nCoV (Novel Coronavirus) IgG/IgM Rapid Test, COVID-19 (NovelCoronavirus) IgG/IgM Rapid Test, COVID-19 (NovelCoronavirus) IgG Rapid Test, COVID 19 (Novel Coronavirus) and M. pneumoniae (Mycoplasma pneumoniae) IgG/IgM Combo Rapid Test, COVID 19 (Novel Coronavirus) and M.pneumoniae (Mycoplasma pneumoniae) IgG Combo Rapid Test, COVID 19 Antigen Rapid Test, COVID 19 and Influenza A+B Antigen Combo Rapid Test, COVID 19 IgG/IgM Test, COVID 19 Antigen Test, SARS-COV-2 RT-qPCR Assay, SARS-CoV-2 (Novel Coronavirus)/Influenza A+B/RSV (Respiratory Syncytial Virus) Antigen Combo Rapid Test, SARS-CoV-2 (Novel Coronavirus)/Influenza A+B/RSV (Respiratory Syncytial Virus)/Adenovirus Antigen Combo Rapid Test, SARS-CoV-2 (Novel Coronavirus)/Influenza A+B/RSV (Respiratory Syncytial Virus)/Adenovirus/ M. pneumoniae (Mycoplasma pneumoniae) Antigen Combo Rapid Test, SARS-CoV-2 Antigen Rapid Test, COVID-19 (Corona Virus Disease 2019) S-RBD (spike protein (S) receptor binding domain (RBD)) IgG Antibody Test |
| 00096370 | 2021-04-22 | MedNet GmbH | Hangzhou AllTest Biotech Co., Ltd. | China | AP: 2019-nCoV (Novel Coronavirus) IgG/IgM Rapid Test, COVID-19 (NovelCoronavirus) IgG/IgM Rapid Test, COVID-19 (Novel Coronavirus) IgG Rapid Test, COVID-19 (Novel Coronavirus) and M.pneumoniae IgG/IgM Combo Rapid Test, COVID-19 (Novel Coronavirus) and M.pneumoniae IgG Combo Rapid Test, COVID-19 (Novel Coronavirus) Antigen Rapid Test, COVID-19 (Novel Coronavirus) IgG/IgM Test, COVID-19 (Novel Coronavirus) Antigen Test, SARS-CoV-2 Antigen Rapid Test, SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test, COVID-19 (Novel Coronavirus) S-RBD IgG Antibody Test |
| 00096041 | 2020-05-29 | Share Info Consultant Service LLC Repräsentanzbüro | Chongqing Western Biomedical Technology Co., Ltd. | China | HN: Virus Transport Kit |
| 00095680 | 2020-05-29 | Share Info Consultant Service LLC Repräsentanzbüro | Redpharm (Changchun) Biotechnology Co.,Ltd | China | HN: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR) |
| 00095322 | 2020-05-29 | Share Info Consultant Service LLC Repräsentanzbüro | Suzhou TianLong Biotechnology Co., Ltd. | China | HN: Novel Coronavirus(2019-nCoV) Nucleic Acid detection Kit |
| 00096375 | 2021-07-21 | Medical Technology Promedt Consulting GmbH | SLSBio Co. Ltd. | Korea, Rep. | HN: SSmarTest COVID19 Spike Protein Ab(IgM/IgG) Test (Model no.:huCOVID19-007); SSmarTest COVID19 Neutralizing Ab Test (Model no.: huCOVID19-006) AP: IVD reagents for infectious disease marker |
| 00096361 | 2020-05-28 | Roche Diagnostics GmbH | HN: PreciControl Anti-SARS-CoV-2 | ||
| 00096258 | 2020-06-04 | Luxus Lebenswelt GmbH | BeiJing Abace Biotechnology Co., Ltd. | China | HN: COVID-19 ELISA Test Kit AP: COVID-19 ELISA Test Kit |
| 00096078 | 2020-06-04 | Luxus Lebenswelt GmbH | BeiJing Abace Biotechnology Co., Ltd. | China | HN: COVID-19 viral antigen detection kit (ELISA) AP: COVID-19 viral antigen detection kit (ELISA) |
| 00095918 | 2020-05-28 | BerkeMed GmbH | Shenzhen HYK Gene Technology Co., Ltd. | China | HN: SARS CoV 2 Nucleic Acid Detection Kit (Fluorescence RT PCR) AP: SARS CoV 2 Nucleic Acid Detection Kit (Fluorescence RT PCR) |
| 00095843 | 2020-05-28 | BerkeMed GmbH | WARETON AND COMPANY TECHNOLOGY Co. LIMITED | Hong Kong | HN: COVID 19(ORF 1ab/N) AP: Novel coronavirus (COVID 19) nucleic acid detection kit |
| 00095825 | 2020-05-28 | Luxus Lebenswelt GmbH | Shanghai Realbio Technology Co. LTD | China | HN: COVID-19 Clinical Sequencing Kit AP: COVID-19 Clinical Sequencing Kit |
| 00095767 | 2020-05-28 | BerkeMed GmbH | Wuhan Considerin Gene&Health Technology CO., Ltd. | China | HN: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit (Colloidal Gold) AP: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit (Colloidal Gold) |
| 00095433 | 2020-05-28 | Luxus Lebenswelt GmbH | JIANGSU DABO PHARMACEUTICAL CO., LTD | China | HN: Nucleic Acid Test for SARS-CoV-2 (RT-PCR) AP: Nucleic Acid Test for SARS-CoV-2 (RT-PCR) |
| 00095298 | 2020-05-28 | Luxus Lebenswelt GmbH | PerGrande BioTech Development Co., Ltd. | China | HN: SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay) AP: SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay) |
| 00096335 | 2021-05-31 | Medical Technology Promedt Consulting GmbH | CALTH Inc. | Korea, Rep. | HN: AllCheck COVID-19 IgG/IgM; LabGun™ COVID-19 IgG/IgM; EZSpeed COVID-19 IgG/IgM; DNALINK FIND COVID19; AllCheck COVID19 Ag; AccuFind COVID19™ Ag; LabGun™ COVID-19 Rapid Antigen Kit; EZSpeed COVID19 Ag; AllCheck COVID-19 IgG; AllCheck COVID19 Ag Nasal |
| 00095671 | 2020-05-26 | Caretechion GmbH | GUANGDONG ARDENT BIOMED Co., Ltd. | China | HN: Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (PCR-fluorescent Probe) |
| 00095631 | 2020-05-25 | Luxus Lebenswelt GmbH | ZhuHai Sinochips Bioscience Co., Ltd. | China | HN: COVID-19 nucleic Real-time PCR test Kit AP: COVID-19 nucleic Real-time PCR test Kit |
| 00095619 | 2020-05-25 | Luxus Lebenswelt GmbH | Hangzhou Bigfish Bio-tech Co., Ltd | China | HN: SARS-CoV-2 Nucleic Acid Detection Kit(Fluorescence RT-PCR) AP: SARS-CoV-2 Nucleic Acid Detection Kit(Fluorescence RT-PCR) |
| 00095506 | 2020-05-25 | Luxus Lebenswelt GmbH | Shanghai Biotecan Pharmaceuticals Co. , Ltd | China | HN: SARS-CoV-2 IgM/IgG Rapid Test by Colloidal Gold Method AP: SARS-CoV-2 IgM/IgG Rapid Test by Colloidal Gold Method |
| 00095497 | 2020-05-25 | Luxus Lebenswelt GmbH | ZHONGSHAN BIO-TECH CO.,LTD. | China | HN: SARS-CoV-2 IgM-IgG (GICA) AP: SARS-CoV-2 IgM-IgG (GICA) |
| 00095470 | 2020-05-25 | MedPath GmbH | Shenzhen Haisian Biotech Co., Ltd | China | HN: COVID-19 IgM/IgG Combo Rapid Test |
| 00095308 | 2020-05-25 | Luxus Lebenswelt GmbH | Beijing Biochem Hengye Science & Technology Development Co., Ltd. | China | HN: SARS-CoV-2 Antibody Test Kit(Collide Gold based Lateral Flow Method) AP: SARS-CoV-2 Antibody Test Kit(Collide Gold based Lateral Flow Method) |
| 00095306 | 2020-05-25 | Luxus Lebenswelt GmbH | Beijing Biochem Hengye Science & Technology Development Co., Ltd. | China | HN: SARS-CoV-2 Real-Time RT-PCR Kit AP: SARS-CoV-2 Real-Time RT-PCR Kit |
| 00096302 | 2020-12-10 | Medical Technology Promedt Consulting GmbH | B-bio Co., Ltd. | Korea, Rep. | HN: ChekR™ COVID-19 IgM/IgG Rapid test; INNOGEN-B™ COVID-19 IgM/IgG Rapid test AP: COVID-19 IgM/IgG Rapid test |
| 00096299 | 2021-05-07 | Medical Technology Promedt Consulting GmbH | Jei Daniel (JD) Biotech Corp. | China | HN: JDBIOTECH New Coronavirus IgG/IgM Rapid Test Kit (COVID-19 IgG/ IgM); SARS-COV-2 (COVID-19) Antigen Rapid Test; SARS-COV-2 and Influenza A+B Ag Combo Rapid Test; JDBIOTECH SARS-CoV-2 RBD nAb (Neutralizing Antibody) Rapid Test |
| 00096111 | 2020-06-09 | MedNet GmbH | MedMira Inc. | Kanada | HN: REVEALCOVID-19 (TM) Total Antibody Test |
| 00096102 | 2020-05-22 | MedNet GmbH | NTBIO Diagnostics Inc. | Kanada | HN: NTBIO COVID-19 IgG/IgM Antibody Test |
| 00095785 | 2020-05-22 | VIROTECH Diagnostics GmbH | AP: IgG, IgM und IgA Konjugate für VIROTECH SARS-CoV-2 ELISA IgG, IgM und IgA | ||
| 00095784 | 2020-05-22 | VIROTECH Diagnostics GmbH | AP: VIROTECH SARS-CoV-2 ELISA zum Nachweis von humanen IgG, IgM und IgA Antikörper im Serum | ||
| 00095505 | 2020-05-20 | Luxus Lebenswelt GmbH | Qingdao Funuo BioMedical Co., Ltd. | China | HN: COVID-19 Multiplex Fluorescent PCR Kit AP: COVID-19 Multiplex Fluorescent PCR Kit |
| 00096166 | 2020-05-19 | LIONEX GmbH | HN: COVID-19 ELISA – Human IgG AP: COVID-19 ELISA – Human IgG |
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| 00095861 | 2020-05-19 | Caretechion GmbH | Yunnan Rare Biotechnology Co., Ltd. | China | HN: COVID-19 Nucleic Acid Detection Kit (Fast Real-Time PCR) |
| 00095665 | 2020-05-19 | Caretechion GmbH | Genobio Pharmaceutical Co., Ltd. | China | AP: COVID-19 IgM/IgG Lateral Flow Assay |
| 00095559 | 2020-05-19 | Caretechion GmbH | Genobio Pharmaceutical Co., Ltd. | China | AP: COVID-19 IgM Lateral Flow Assay |
| 00095558 | 2020-05-19 | Caretechion GmbH | Genobio Pharmaceutical Co., Ltd. | China | AP: COVID-19 IgG Lateral Flow Assay |
| 00095458 | 2020-05-19 | Caretechion GmbH | 3D Biomedicine Science & Technology Co., Limited. | China | AP: ANDiS SARS-CoV-2 and Influenza A/B RT-qPCR Detection Kit |
| 00095283 | 2020-05-19 | MedPath GmbH | Shanghai Outdo Biotech Co., Ltd. | China | HN: Novel Coronavirus (SARS-CoV-2) Antibody (IgM/IgG) Test |
| 00095655 | 2020-05-18 | Shanghai International Holding Corporation GmbH (Europe) | Gaobeidian PRISES Biotechnology Co., Ltd. | China | HN: PRISES AP: COVID-19IgG/IgM Test(Colloidal Gold) |
| 00095579 | 2020-05-18 | Shanghai International Holding Corporation GmbH (Europe) | Shanghai Rendu Biotechnology Co., Ltd. | China | HN: Rendu AP: AmpSure® 2019-nCoV RNA Assay |
| 00095434 | 2021-05-19 | Luxus Lebenswelt GmbH | Jiangsu Dablood Pharmaceutical Co.,Ltd. | China | HN: Diagnostic Kit for Detection of IgG Antibody to SARS-CoV-2(Colloidal Gold) AP: Diagnostic Kit for Detection of IgG Antibody to SARS-CoV-2(Colloidal Gold) |
| 00095432 | 2021-05-19 | Luxus Lebenswelt GmbH | Jiangsu Dablood Pharmaceutical Co.,Ltd. | China | HN: Diagnostic Kit for Detection of IgM Antibody to SARS-CoV-2(Colloidal Gold) AP: Diagnostic Kit for Detection of IgM Antibody to SARS-CoV-2(Colloidal Gold) |
| 00095431 | 2021-05-19 | Luxus Lebenswelt GmbH | Jiangsu Dablood Pharmaceutical Co.,Ltd. | China | HN: Diagnostic Kit for Detection of IgG/ IgM Antibody to SARS-CoV-2(Colloidal Gold) AP: Diagnostic Kit for Detection of IgG/ IgM Antibody to SARS-CoV-2(Colloidal Gold) |
| 00096186 | 2020-05-15 | Medical Device Safety Service GmbH | WELLS BIO, INC. | Korea, Rep. | HN: careUS™ COVID-19 IgM / IgG |
| 00096112 | 2020-05-15 | MedPath GmbH | Suzhou Topmedlab Medical Science and Technology Co.,Ltd. | China | HN: (COVID-19)IgG/IgM Rapid test kit (dyed micro-spheres) |
| 00096075 | 2020-05-15 | mdi Europa GmbH | Nano-Ditech Corporation | Vereinigte Staaten von Amerika | AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION |
| 00096065 | 2021-06-25 | NovaTec Immundiagnostica GmbH | HN: GSD NovaPrime SARS-CoV-2 (COVID-19) | ||
| 00096023 | 2020-05-15 | NovaTec Immundiagnostica GmbH | AP: SARS-CoV-2 (COVID-19) IgM ELISA | ||
| 00096022 | 2020-05-15 | NovaTec Immundiagnostica GmbH | AP: SARS-CoV-2 (COVID-19) IgG ELISA | ||
| 00096021 | 2020-05-15 | NovaTec Immundiagnostica GmbH | AP: SARS-CoV-2 (COVID-19) IgA ELISA | ||
| 00096017 | 2020-05-14 | BAG Diagnostics GmbH | HN: ViroQ SARS-CoV-2 | ||
| 00096013 | 2020-05-15 | Bosch Healthcare Solutions GmbH | HN: Vivalytic VRI | ||
| 00095882 | 2020-05-15 | mdi Europa GmbH | GeneReach Biotechnology Corporation | Taiwan | AP: Other Virology - NA Reagents |
| 00095838 | 2020-05-15 | Medite Medical GmbH | BioSino Bio-Technology and Science Inc. | China | HN: SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) AP: SARS-CoV-2 Antikörper Test |
| 00095697 | 2020-05-15 | MedPath GmbH | Tianjin GensKey Medical Technology Co., Ltd. | China | HN: GensKey SARS-CoV-2 Analysis Software |
| 00095508 | 2020-05-15 | Luxus Lebenswelt GmbH | Shanghai GeneoDx Biotechnology Co., Ltd | China | HN: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Real Time PCR) AP: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Real Time PCR) |
| 00095499 | 2020-05-15 | Luxus Lebenswelt GmbH | Shanghai BioGerm Medical Technology Co., Ltd | China | HN: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) AP: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) |
| 00095392 | 2021-08-03 | MedNet GmbH | Beijing Diagreat Biotechnologies Co., Ltd | China | HN: 2019-nCoV specific test |
| 00095071 | 2021-08-03 | MedNet GmbH | Beijing Diagreat Biotechnologies Co., Ltd | China | HN: 2019-nCoV specific test |
| 00095884 | 2020-05-14 | jtc-diagnostics | Ideal Tashkhis Atieh Co. | Iran, Islam. Rep. | HN: SARS-CoV-2 IgG ELISA AP: IgG ELISA |
| 00095883 | 2020-05-14 | jtc-diagnostics | Ideal Tashkhis Atieh Co. | Iran, Islam. Rep. | HN: SARS-CoV-2 IgM ELISA AP: IgM ELISA |
| 00095860 | 2020-05-14 | MedNet EC-REP GmbH | Artron Laboratories Inc. | Kanada | AP: COVID-19 IgM/IgG Antibody Test |
| 00095752 | 2020-05-14 | jtc-diagnostics | Pishtaz Teb | Iran, Islam. Rep. | HN: COVID-19 One-Step RT-PCR Kit AP: RT-PCR Kit |
| 00095747 | 2020-05-14 | jtc-diagnostics | Pishtaz Teb Zaman Diagnostics Co. | Iran, Islam. Rep. | HN: SARS-CoV-2 IgG ELISA AP: IgG ELISA |
| 00095640 | 2020-05-13 | Luxus Lebenswelt GmbH | Shandong ACV Biotechnology Co., Ltd. | China | HN: SARS-CoV-19(ORF1ab) / N Gene;Nucleic Acid Detection Kit （Fluorescence Qualitative RT-PCR） AP: SARS-CoV-2（ORF1ab / N Gene）Nucleic Acid Detection Kit （Fluorescence Qualitative RT-PCR） |
| 00095577 | 2020-05-13 | Luxus Lebenswelt GmbH | MyGenostics(Chongqing) gene technology Co. LTD. | China | HN: SARS-CoV-2 Real-time RT-PCR Diagnostic Panel AP: SARS-CoV-2 Real-time RT-PCR Diagnostic Panel |
| 00095555 | 2020-05-14 | Caretechion GmbH | Nanjing Norman Biological Technology Co., Ltd. | China | AP: Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold) |
| 00095507 | 2020-05-13 | Luxus Lebenswelt GmbH | Shanghai Biotecan Pharmaceuticals Co. , Ltd | China | HN: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Real Time PCR) AP: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Real Time PCR) |
| 00095242 | 2020-05-13 | Luxus Lebenswelt GmbH | GZ Vision Medicals instrument Co. LTD | China | HN: SARS-CoV-2 Clinical Sequencing Assay AP: SARS-CoV-2 Clinical Sequencing Assay |
| 00095107 | 2020-05-14 | MedPath GmbH | Shanghai Focusgen Biotechnology Limited Company | China | HN: Novel coronavirus (2019-nCoV) Real-time PCR kit |
| 00096106 | 2020-05-12 | Medical Device Safety Service GmbH | W.H.P.M. Bioresearch & Technology Co., Ltd. | China | HN: COVISURE™ COVID-19 IgM/IgG Rapid Test (Colloidal Gold Immuno-chromatography) |
| 00095840 | 2020-05-12 | MedNet EC-REP GmbH | Labnovation Technologies, Inc. | China | HN: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit (Immunochromatography/ Colloidal Gold) |
| 00095437 | 2020-05-12 | Luxus Lebenswelt GmbH | Genetron Health (Beijing) Co., Ltd. | China | HN: Detection Kit for Novel Coronavirus(SARS-CoV-2)RNA(PCR-Fluorescence Probing) AP: Detection Kit for Novel Coronavirus(SARS-CoV-2)RNA(PCR-Fluorescence Probing) |
| 00096084 | 2020-05-11 | HAIN LIFESCIENCE GmbH | HN: FluoroType® SARS-CoV-2 plus VER 1.0 | ||
| 00096040 | 2020-05-11 | EUROIMMUN Medizinische Labordiagnostika AG | AP: Anti-SARS-CoV-2-NCP-ELISA | ||
| 00096081 | 2021-03-26 | Medical Device Safety Service GmbH | Access Bio, Inc. | Vereinigte Staaten von Amerika | HN: CareStart™ COVID-19 IgM/IgG; Easy Check COVID-19 IgM/IgG™; Rapid Response™ Liberty COVID-19 IgG/IgM; CareStart™ COVID-19 Antigen; KarmaCare™ COVID-19 Antigen |
| 00095653 | 2020-05-08 | Luxus Lebenswelt GmbH | Jiangxi YeLi Medical Apparatus Co., Ltd | China | HN: Universal Kit for DNA Sequence AP: Universal Kit for DNA Sequence |
| 00095305 | 2020-05-08 | Luxus Lebenswelt GmbH | Jiangxi YeLi Medical Apparatus Co., Ltd | China | HN: Detection Kit for 2019-nCoV Antibody(Quantum Dot Beads Immunochromatographic Method) AP: Detection Kit for 2019-nCoV Antibody(Quantum Dot Beads Immunochromatographic Method) |
| 00095304 | 2020-05-08 | Luxus Lebenswelt GmbH | Jiangxi YeLi Medical Apparatus Co., Ltd | China | HN: Detection Kit for 2019-nCoV Antibody(Colloidal Gold Immunochromatographic Method) AP: Detection Kit for 2019-nCoV Antibody(Colloidal Gold Immunochromatographic Method) |
| 00095303 | 2020-05-08 | Luxus Lebenswelt GmbH | Jiangxi YeLi Medical Apparatus Co., Ltd | China | HN: Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing) AP: Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing) |
| 00095299 | 2020-05-08 | Luxus Lebenswelt GmbH | Innovation Biotechnology Co., Ltd.Jiangsu | China | HN: Novel Coronavirus (SARS-CoV-2) IgG/IgM Antibody Test Kit (Immunochromatography) AP: Novel Coronavirus (SARS-CoV-2) IgG/IgM Antibody Test Kit (Immunochromatography) |
| 00096073 | 2020-05-06 | MIKROGEN GmbH | HN: recomWell SARS-CoV-2 IgG | ||
| 00095937 | 2021-04-01 | Medical Device Safety Service GmbH | MiRXES Pte Ltd | Singapur | HN: MiRXES Fortitude Kit 2.0E; MiRXES Fortitude Kit 2.1; MiRXES Fortitude Kit 3.0; MiRXES CoVClear |
| 00095902 | 2020-05-06 | VIRAMED Biotech AG | HN: SARS-CoV-2 ViraChip IgG Test Kit | ||
| 00095901 | 2020-05-06 | VIRAMED Biotech AG | HN: SARS-CoV-2 ViraChip IgA Test Kit | ||
| 00095863 | 2020-05-06 | Demeditec Diagnostics GmbH | AP: COVID-19 (SARS-CoV-2) | ||
| 00095733 | 2020-05-06 | Shanghai International Holding Corporation GmbH (Europe) | Triplex International Biosciences (China) Co., LTD. | China | HN: Triplex AP: SARS-CoV-2 Nucleic Acid Detection Kit (RT-PCR Fluorescence Probing Method) |
| 00095719 | 2020-05-07 | MIKROGEN GmbH | HN: ampliCube Coronavirus SARS-CoV-2 | ||
| 00095700 | 2020-05-06 | Shanghai International Holding Corporation GmbH (Europe) | Triplex International Biosciences (China) Co., LTD. | China | HN: Triplex AP: SARS-CoV-2 IgM/IgG Rapid Test Kit (Colloidal Gold) |
| 00095457 | 2020-05-06 | Medwheat Tech Service GmbH | HangZhou Lifereal biotechnology CO.,Ltd | China | HN: COVID-19 nucleic acid (RNA) Detection kit (Real-time Fluorescent PCR method) |
| 00095435 | 2020-05-06 | Medwheat Tech Service GmbH | HangZhou Lifereal biotechnology CO.,Ltd | China | HN: COVID-19 nucleic acid (RNA) POCT detection kit (AIGS real-time fluorescent PCR method) |
| 00095388 | 2020-05-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | HN: Lifotronic AP: SARS-CoV-2 IgM (Electrochemiluminescence Immunoassay) |
| 00095366 | 2020-05-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | HN: Lifotronic AP: SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay) |
| 00095294 | 2020-05-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | HN: Lifotronic AP: SARS-CoV-2 IgM Assay Kits (Lateral Flow Immunoassay) |
| 00095293 | 2020-05-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Lifotronic Technology Co., Ltd. | China | HN: Lifotronic AP: SARS-CoV-2 IgG Assay Kits (Lateral Flow Immunoassay) |
| 00096071 | 2021-05-07 | Medical Technology Promedt Consulting GmbH | DxGen Corp. | Korea, Rep. | HN: Epithod®616 COVID-19 IgM/IgG Test Kit (Ep.616COVID19); SpeedCheck COVID-19 IgM/IgG Test Kit (Ep.616COVID19); EDGC™ RapidCheck COVID-19 IgM/IgG Test Kit (Ep.616COVID19); Epithod® SARS CoV 2 qAg Test Kit (Model: Dx.CoV2qAg); Epithod® 616 COVID-19 Ag Test Kit (Model: Ep.616COVID19Ag); Epithod® 616 COVID-19 IgG Test Kit (Model: Ep.616COVID19G); Epithod® SARS- CoV-2 IgG (Model: Dx.CoV2IgG) |
| 00095876 | 2020-05-05 | MedNet EC-REP GmbH | Cell ID Pte Ltd. | Singapur | HN: Smart COVID-19 IgM/IgG RDT |
| 00095580 | 2020-05-05 | Shanghai International Holding Corporation GmbH (Europe) | Guangzhou Improve Medical Instruments Co., Ltd | China | HN: Improve AP: SARS-CoV-2 Test Kit (Real-time PCR) |
| 00095554 | 2020-05-05 | Shanghai International Holding Corporation GmbH (Europe) | Zybio Inc. | China | HN: Zybio AP: SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) |
| 00095523 | 2020-05-05 | Shanghai International Holding Corporation GmbH (Europe) | Rayto Life and Analytical Sciences Co., Ltd. | China | HN: Rayto AP: Novel CoronaVirus IgM Antibody (2019-nCoV IgM) Reagent Kit (Chemiluminescent Immunoassay) |
| 00095522 | 2020-05-05 | Shanghai International Holding Corporation GmbH (Europe) | Rayto Life and Analytical Sciences Co., Ltd. | China | HN: Rayto AP: Novel CoronaVirus IgG Antibody (2019-nCoV IgG) Reagent Kit (Chemiluminescent Immunoassay) |
| 00095489 | 2020-05-05 | Shanghai International Holding Corporation GmbH (Europe) | Co-Innovation Biotech Co. Ltd | China | HN: Co-Innovation AP: One Step 2019-Novel Coronavirus (2019-nCoV) IgG/IgM Test Cassette |
| 00095473 | 2021-01-06 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen BOSH Diagnostics, Ltd. | China | HN: Bosh AP: SARS-CoV-2 IgM & IgG Rapid Test |
| 00095296 | 2020-05-05 | Immundiagnostik AG | HN: MutaPLEX® Coronavirus | ||
| 00095164 | 2020-05-05 | Luxus Lebenswelt GmbH | Nantong Diagnos Biotechnology Co.,Ltd. | China | HN: (2019-nCoV)New coronavirus Antibody Test (Colloidal Gold) AP: (2019-nCoV)New coronavirus Antibody Test (Colloidal Gold) |
| 00096002 | 2020-05-04 | Roche Diagnostics GmbH | HN: Elecsys Anti-SARS-CoV-2 | ||
| 00095654 | 2020-05-04 | Luxus Lebenswelt GmbH | Hangzhou Genesea Biotechnology Co. Ltd | China | HN: COVID-19 IgG/IgM Rapid Test Cassette AP: COVID-19 IgG/IgM Rapid Test Cassette |
| 00095985 | 2020-04-30 | Medical Technology Promedt Consulting GmbH | Joonghun Pharmaceutical Co., Ltd. | Korea, Rep. | HN: JD COVID-19 qRT-PCR Kit AP: IVD genetic test reagent for high risk infectious diseases marker |
| 00095975 | 2020-10-20 | MedNet GmbH | ACON Biotech (Hangzhou) Co., Ltd. | China | HN: ACON; Quik-Check; LH AP: SARS-CoV-2 IgG/IgM Rapid Test |
| 00095972 | 2021-04-22 | altona Diagnostics GmbH | HN: RealStar SARS-CoV-2 RT-PCR Kit 1.0 | ||
| 00095849 | 2020-04-30 | Shanghai International Holding Corporation GmbH (Europe) | Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. | China | HN: Konsung AP: Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold) |
| 00095810 | 2020-04-30 | Pharmact GmbH | HN: BelTEST It ! SARS-CoV-2 specific IgM / IgG | ||
| 00095803 | 2020-04-30 | NovaTec Immundiagnostica GmbH | HN: NovaLisa AP: SARS-CoV-2 (COVID-19) IgM |
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| 00095802 | 2020-04-30 | NovaTec Immundiagnostica GmbH | HN: NovaLisa AP: SARS-CoV-2 (COVID-19) IgA |
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| 00095801 | 2020-04-30 | NovaTec Immundiagnostica GmbH | HN: NovaLisa AP: SARS-CoV-2 (COVID-19) IgG |
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| 00095589 | 2020-05-06 | MedNet EC-REP GmbH | Beijing Beier Bioengineering Co., Ltd | China | AP: 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P) |
| 00095560 | 2020-04-30 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Sejoy Electronics & Instruments CO., LTD. | China | HN: Sejoy AP: COVID-19 lgG/lgM Rapid Test Cassette |
| 00095553 | 2020-04-30 | Shanghai International Holding Corporation GmbH (Europe) | Maccura Biotechnology Co., Ltd. | China | HN: Maccura AP: SARS-CoV-2 IgM (CLIA) |
| 00095552 | 2020-04-30 | Shanghai International Holding Corporation GmbH (Europe) | Maccura Biotechnology Co., Ltd. | China | HN: Maccura AP: SARS-CoV-2 IgG (CLIA) |
| 00095512 | 2020-04-30 | Luxus Lebenswelt GmbH | HANGZHOU BIOER TECHNOLOGY CO., LTD. | China | HN: SARS-CoV-2 Nucleic Acid Detection Kit(Fluorescence RT-PCR) AP: SARS-CoV-2 Nucleic Acid Detection Kit(Fluorescence RT-PCR) |
| 00095464 | 2020-04-30 | MedNet EC-REP GmbH | Beijing Zhongjian Antai Diagnostic Technology Co., Ltd. | China | AP: Corona Virus (COVID-19) Combined (IgA/IgM/IgG) Rapid Test |
| 00095463 | 2020-04-30 | Luxus Lebenswelt GmbH | Surge Medical Inc | China | HN: COVID-19 IgG/IgM Antibody Assay Kit(Colloidal Gold Method) AP: COVID-19 IgG/IgM Antibody Assay Kit(Colloidal Gold Method) |
| 00095403 | 2020-04-29 | Shanghai International Holding Corporation GmbH (Europe) | Blue Cross Bio-Medical (Beijing) Co., Ltd. | China | HN: Blue Cross AP: One Step Novel Coronavirus (SARS-CoV-2) IgM / IgG Test Kit |
| 00095395 | 2020-04-29 | Shanghai International Holding Corporation GmbH (Europe) | Shanghai Chemtron Biotech.Co.,Ltd. | China | HN: Chemtron AP: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Diagnostic Kit (Colloidal Gold) |
| 00095394 | 2020-04-29 | Shanghai International Holding Corporation GmbH (Europe) | Shanghai Chemtron Biotech.Co.,Ltd. | China | HN: Chemtron AP: Novel Coronavirus (2019-nCoV) IgM Antibody Diagnostic Kit (Colloidal Gold) |
| 00095391 | 2020-04-29 | Shanghai International Holding Corporation GmbH (Europe) | Blue Cross Bio-Medical (Beijing) Co., Ltd. | China | HN: Blue Cross AP: One Step Novel Coronavirus（SARS-CoV-2） IgM / IgG Test Kit |
| 00095343 | 2020-04-29 | Shanghai International Holding Corporation GmbH (Europe) | BCT Systems Co., Ltd. | China | HN: BCT AP: One Step Novel Coronavirus (COVID-19) Test (Immunochromatography Assay) |
| 00095336 | 2020-04-29 | Shanghai International Holding Corporation GmbH (Europe) | HaploX Biotechnology Co., Ltd. | China | HN: HaploX AP: RT-PCR Kit for Detecting SARS-CoV-2(Real-time fluorescent PCR) |
| 00095320 | 2020-11-02 | Shanghai International Holding Corporation GmbH (Europe) | Hecin Scientific Inc. | China | HN: Hecin AP: SARS-CoV-2 Nucleic Acid Test Kit (PCR- fluorescence probe method) |
| 00095318 | 2020-09-10 | Shanghai International Holding Corporation GmbH (Europe) | Hecin Scientific Inc. | China | HN: Hecin AP: COVID-19 IgM Antibody Test Kit (colloidal gold method) |
| 00095125 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Maccura Biotechnology Co., Ltd. | China | HN: Maccura AP: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method |
| 00094623 | 2020-04-29 | Shanghai International Holding Corporation GmbH (Europe) | Zhejiang Orient Gene Biotech Co., Ltd. | China | HN: Orient AP: Coronavirus Detection Kit (Fluorescence PCR) |
| 00094622 | 2020-04-29 | Shanghai International Holding Corporation GmbH (Europe) | Zhejiang Orient Gene Biotech Co., Ltd. | China | HN: Orient AP: 2019-nCoV and SARS-CoV Detection Kit (Fluorescence PCR) |
| 00095926 | 2020-04-28 | Medical Device Safety Service GmbH | ACON Laboratories, Inc. | Vereinigte Staaten von Amerika | HN: ACON® SARS-CoV-2 IgG/IgM Rapid Test |
| 00095326 | 2020-04-28 | Luxus Lebenswelt GmbH | Anhui Anke Biotechnology(Group) Co., Ltd. | China | HN: SARS-CoV-2 (COVID-19) lgM/lgG Antibody Fast Detection Kit (Colloidal Gold) AP: SARS-CoV-2 (COVID-19) lgM/lgG Antibody Fast Detection Kit (Colloidal Gold) |
| 00095904 | 2020-07-02 | Medical Technology Promedt Consulting GmbH | EuDiPia Co., Ltd. | Korea, Rep. | HN: EuDx™ COVID-19 Detection Kit; EuDx™ COVID-19 Multiplex Detection Kit |
| 00095903 | 2021-06-16 | Medical Technology Promedt Consulting GmbH | Green Cross Medical Science Corporation | Korea, Rep. | HN: GENEDIA W COVID-19 IgM/IgG; GENEDIA W ONE COVID-19 IgM/IgG; GENEDIA W COVID-19 Ag; GENEDIA Quantum COVID-19 Ag; GENEDIA W COVID-19 Ag |
| 00095812 | 2021-03-11 | Medical Device Safety Service GmbH | PlexBio Co., Ltd. | Taiwan | HN: IntelliPlex SARS-CoV-2 Detection Kit; IntelliPlex SARS-CoV-2 Detection Test Kit |
| 00095809 | 2020-04-27 | Medical Device Safety Service GmbH | Access Bio, Inc. | Vereinigte Staaten von Amerika | HN: CareStart™ COVID-19 MDx RT-PCR |
| 00095788 | 2020-04-27 | GA Generic Assays GmbH | HN: GA CoV-2 IgG + AP: 3940 |
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| 00095787 | 2020-04-27 | GA Generic Assays GmbH | HN: GA CoV-2 IgM AP: 3930 |
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| 00095786 | 2020-04-27 | GA Generic Assays GmbH | HN: GA CoV-2 IgG AP: 3920 |
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| 00095670 | 2021-01-07 | JaviTech e.K. | Genesystem Co., Ltd. | Korea, Rep. | HN: SMARTCHEK® AP: Gene analysis reagent for in-vitro Diagnostic Device |
| 00095829 | 2020-04-24 | Medical Device Safety Service GmbH | Guangzhou Darui Biotechnology Co.,Ltd. | China | HN: SARS-Cov-2 IgG Antibody Detection Kit (Colloidal Gold); SARS-Cov-2 IgM Antibody Detection Kit (Colloidal Gold) |
| 00095828 | 2020-04-24 | Medical Device Safety Service GmbH | Guangzhou Darui Biotechnology Co.,Ltd. | China | HN: SARS-Cov-2 IgM Antibody Detection Kit (ELISA); SARS-Cov-2 IgG Antibody Detection Kit (ELISA) |
| 00095886 | 2021-09-17 | Medical Technology Promedt Consulting GmbH | Asan Pharmaceutical Co., Ltd. | Korea, Rep. | HN: Asan Easy Test® COVID-19 IgG/IgM; Product name: Rapid detection kit for SARS-CoV-2 antigens (Model name: Asan Easy Test® COVID-19 Ag); Product name: Rapid detection kit for influenza virus A, B and SARS-CoV-2 antigens (Model name: Asan Easy Test® Flu/COVID-19 Ag Combo); Product name: Rapid detection kit of IgG and IgM antibodies to SARS-CoV-2 (Model name: Asan Easy Test® COVID-19 IgG/IgM (N)); Product name: KNAX-SMART SARS-CoV-2 IgM/IgG (Model name: KX-IDB1); Product name: KNAX-SMART SARS-CoV-2 Ag (Model name: KX-IDG1); KNAX-SMART SARS-CoV-2 IgM/IgG (N) (Model name: KX-IDB2); KNAX-SMART SARS-CoV-2, Influenza A&B Ag Combo (Model name: KX-IDC1) |
| 00095703 | 2020-06-09 | Vela Diagnostics Germany GmbH | Vela Operations Singapore Pte Ltd | Singapur | HN: ViroKey SARS-CoV-2 RT-PCR Test |
| 00095684 | 2020-04-22 | ScheBo Biotech AG | HN: ScheBo SARS-CoV-2 Quick AP: SARS-CoV-2 IgG/IgM Antibody Test Kit |
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| 00095850 | 2021-01-26 | Medical Technology Promedt Consulting GmbH | General Biologicals Corporation | Taiwan | HN: GB SARS-CoV-2 Real- Time RT-PCR; GBC SimPrep SARS-CoV-2 RT-PCR; GB LabPrep Viral DNA/RNA Mini Kit; GB SARS-CoV-2 Influenza A/B Multiplex PCR |
| 00095790 | 2021-01-13 | mdi Europa GmbH | Schweitzer Biotech Company Ltd. | Taiwan | AP: OTHER OTHER GENETIC TESTS |
| 00095789 | 2020-04-21 | mdi Europa GmbH | Medigen Vaccine Biologics Corp. | Taiwan | AP: OTHER OTHER GENETIC TESTS |
| 00095168 | 2020-04-21 | Luxus Lebenswelt GmbH | Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. | China | HN: SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) AP: SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) |
| 00095474 | 2020-04-20 | Shanghai International Holding Corporation GmbH (Europe) | Zybio Inc. | China | HN: Zybio AP: SARS-CoV-2 IgM IgG Antibody Assay Kit (Colloidal Gold Method) |
| 00095297 | 2020-04-20 | Shanghai International Holding Corporation GmbH (Europe) | Healgen Scientific Limited Liability Company | Vereinigte Staaten von Amerika | HN: Healgen AP: 2019-nCoV Direct qPCR Kit |
| 00095026 | 2020-04-20 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Danwei Biotechnology Co.Ltd. | China | HN: Danwei AP: 2019-nCoV Direct qPCR Kit |
| 00095769 | 2020-04-17 | MedNet GmbH | Trentron Biomedical Ltd. | Taiwan | HN: VitaPCR AP: VitaPCR SARS-CoV-2 External Control Set |
| 00095292 | 2020-04-17 | MedNet GmbH | Trentron Biomedical Ltd. | Taiwan | HN: VitaPCR AP: VitaPCR SARS-CoV-2 Assay |
| 00095793 | 2020-06-29 | Medical Technology Promedt Consulting GmbH | Atlas Link Technology Co., Ltd. | China | HN: NOVA Test® COVID-19 IgG/IgM Antibody Test (Colloidal Gold) |
| 00095702 | 2020-04-15 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 Ag Diagnostic Test Kit (Microfluidic chemiluminescence) |
| 00095563 | 2020-04-15 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 Ab Diagnostic Test Kit (Microfluidic chemiluminescence) |
| 00095741 | 2020-04-14 | Abbott Rapid Diagnostics Jena GmbH | HN: Panbio COVID-19 IgG/IgM Rapid Test Device (Fingerstick Whole Blood/Venous Whole Blood/Serum/Plasma) | ||
| 00095683 | 2020-06-02 | KTR Europe GmbH | DowGene Co., Ltd. | Korea, Rep. | HN: Dow QuickFinderTM 2019-nCoV Real time PCR Kit, Dow QuickFinder™-G 2019-nCoV Real-time PCR Kit AP: PCR Kit DG-CV0201, DG-CV0301 |
| 00095566 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 IgG Ab Diagnostic Test Kit (Microfluidic chemiluminescence) |
| 00095565 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 IgG/IgM Ab Diagnostic Test kit (Colloidal Gold) |
| 00095562 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Watmind Medical Co., Ltd. | China | HN: Watmind AP: SARS-CoV-2 IgM Ab Diagnostic Test Kit (Microfluidic chemiluminescence) |
| 00095371 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Zhongshan Chuangyi Biochemical Engineering Co., Ltd. | China | HN: Chuangyi AP: COVID-19 IgM/IgG Detection Kit (Immunofluorescence) |
| 00095291 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Changsha Sinocare Inc. | China | HN: Sinocare AP: SARS-CoV-2 IgM Antibody Test Strip (Colloidal Gold Method) |
| 00095290 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Changsha Sinocare Inc. | China | HN: Sinocare AP: SARS-CoV-2 IgG Antibody Test Strip (Colloidal Gold Method) |
| 00095288 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Changsha Sinocare Inc. | China | HN: Sinocare AP: SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method) |
| 00095214 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Sichuan Xincheng Biological Co., Ltd. | China | HN: Xincheng AP: SARS-Cov-2 IgG/M Antibody Assay Kit by Immunofluorescence Chromatography Method |
| 00095059 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Healgen Scientific Limited Liability Company | Vereinigte Staaten von Amerika | HN: Healgen AP: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) |
| 00095029 | 2020-04-14 | Shanghai International Holding Corporation GmbH (Europe) | Zhejiang Orient Gene Biotech Co.,LTD | China | AP: SARS-CoV-2 Detection Kit (Fluorescence PCR) |
| 00094621 | 2020-07-23 | Shanghai International Holding Corporation GmbH (Europe) | Zhejiang Orient Gene Biotech Co., Ltd. | China | HN: Orient AP: Coronavirus Ag Rapid Test Cassette (Swab) |
| 00095712 | 2020-04-08 | Medical Technology Promedt Consulting GmbH | GeneOne Diagnostic Corporation | Taiwan | HN: GeneOne COVID-19 Nucleic Acid Diagnostic Kit |
| 00095501 | 2020-04-09 | Luxus Lebenswelt GmbH | Zhengzhou Fortune Bioscience Co., Ltd | China | HN: COVID-19 IgG Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) AP: COVID-19 IgG Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) |
| 00095139 | 2020-04-09 | Luxus Lebenswelt GmbH | Shanghai Liangrun Biomedicine Technology Co.,Ltd. | China | HN: Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19 AP: Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19 |
| 00095519 | 2020-04-07 | MedNet EC-REP GmbH | Wuhan EasyDiagnosis Biomedicine Co., Ltd. | China | AP: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit |
| 00095365 | 2020-04-07 | Shanghai International Holding Corporation GmbH (Europe) | CITUS DIAGNOSTICS INC | Kanada | HN: CITUS AP: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) |
| 00095315 | 2020-04-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Yilifang Biotech CO., LTD. | China | HN: Yilifang AP: SARS-CoV-2 Nucleic Acid Detection Kit (Real-Time PCR) |
| 00095281 | 2020-04-07 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Yilifang Biotech CO., LTD. | China | HN: Yilifang AP: COVID-19 IgG/IgM Rapid Test Kit (colloidal gold) |
| 00095280 | 2020-04-07 | Shanghai International Holding Corporation GmbH (Europe) | Nantong Egens Biotechnology Co., Ltd | China | HN: Egens AP: COVID-19 IgG/IgM Rapid Test Kit |
| 00095226 | 2020-11-27 | MedNet EC-REP GmbH | Wuhan EasyDiagnosis Biomedicine Co., Ltd. | China | AP: COVID-19 (SARS-CoV-2) nucleic acid test kit |
| 00095100 | 2020-04-07 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Biotest Biotech Co., Ltd. | China | HN: Biotes AP: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) |
| 00095587 | 2020-04-06 | EUROIMMUN Medizinische Labordiagnostika AG | AP: EURORealTime SARS-CoV-2 | ||
| 00095536 | 2020-04-06 | Shanghai International Holding Corporation GmbH (Europe) | Zhongshan Chuangyi Biochemical Engineering Co., Ltd. | China | HN: Chuangyi AP: COVID-19 IgM/IgG Detection Kit (Colloidal Gold) |
| 00095309 | 2020-10-02 | Medical Device Safety Service GmbH | Epitope Diagnostics, Inc. | Vereinigte Staaten von Amerika | HN: EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit; EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit; EDI™ COVID-19 Nucleocapsid IgG Quantitative ELISA Kit |
| 00095124 | 2020-04-06 | Shanghai International Holding Corporation GmbH (Europe) | Maccura Biotechnology Co., Ltd. | China | HN: Maccura AP: SARS-CoV-2 Fluorescent PCR |
| 00095667 | 2021-07-27 | Medical Technology Promedt Consulting GmbH | OPTOLANE Technologies, Inc. | Korea, Rep. | HN: Kaira 2019-nCoV Detection Kit; Dr. PCR™ Di20K COVID-19 Detection kit; Direct Dr. PCR™ SARS-CoV-2 Detection kit; Kaira™ COVID-19/Flu Detection kit; Dr. PCR™ DiS 20K SARS-CoV-2 Detection kit |
| 00095549 | 2020-04-03 | Share Info Consultant Service LLC Repräsentanzbüro | Chongqing Western Biomedical Technology Co,Ltd. | China | HN: Nucleic Acid Detection Kit for Novel Coronavirus (COVID-19) One-Step Taqman qPCR |
| 00095137 | 2020-04-03 | nal von minden GmbH | AP: COVID-19 lgG/lgM Test | ||
| 00095656 | 2020-04-02 | Medical Technology Promedt Consulting GmbH | Medical Innovation Ventures Sdn. Bhd. | Malaysia | HN: GenoAmp® Real-Time RT-PCR Flu A/Flu B/SARS-CoV-2/MERS-CoV |
| 00095633 | 2021-01-29 | Medical Technology Promedt Consulting GmbH | Diagnostics for the Real World, Ltd. | Vereinigte Staaten von Amerika | HN: SAMBA II SARS-CoV-2 Test |
| 00095596 | 2021-09-01 | Medical Device Safety Service GmbH | BTNX, Inc. | Kanada | HN: Rapid Response™ COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma); Rapid Response™ COVID-19 IgG/IgM Rapid Test Device; Rapid Response™ Liberty COVID-19 IgG/IgM Test (Whole Blood/Serum/Plasma); Rapid Response™ COVID-19 Antigen Rapid Test Device; Rapid Response™ COVID-19 Antigen Rapid Test Cassette; Rapid Response™ COVID-19 Antigen Rapid Test Cassette (Oral Fluid); Rapid Response™ COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab); Rapid Response® COVID-19 Antigen Saliva Test Kit;Rapid Response® SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette |
| 00095595 | 2021-09-17 | Medical Technology Promedt Consulting GmbH | Biolidics Ltd | Singapur | HN: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold); ClearEpi™ SARS-CoV-2 Antigen Rapid Test; ClearEpi™ SARS-CoV-2 Neutralising Antibody Rapid Test |
| 00095568 | 2020-04-01 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | HN: Mindray AP: Severe Acute Respiratory Syndrome Coronavirus 2 IgM (CLIA) |
| 00095567 | 2020-04-01 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | HN: Mindray AP: Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) |
| 00095410 | 2020-11-30 | EUROIMMUN Medizinische Labordiagnostika AG | AP: Anti-SARS-CoV-2-ELISA | ||
| 00095387 | 2020-04-02 | ABBOTT GmbH | Abbott Molecular Inc. | Vereinigte Staaten von Amerika | HN: Abbott RealTime SARS-CoV-2 Amplification Reagent Kit (9N77-90) |
| 00095386 | 2020-04-02 | ABBOTT GmbH | Abbott Molecular Inc. | Vereinigte Staaten von Amerika | HN: Abbott RealTime SARS-CoV-2 Control Kit (9N77-80) |
| 00095385 | 2020-04-02 | ABBOTT GmbH | Abbott Molecular Inc. | Vereinigte Staaten von Amerika | HN: Abbott RealTime SARS-CoV-2 Application CD-ROM (9N77-01) |
| 00095316 | 2020-05-25 | MedNet EC-REP GmbH | Qingdao Hightop Biotech Co. Ltd. | China | AP: SARS-CoV-2 IgM/IgG Antibody Rapid Test, SARS-CoV-2 IgG Antibody Rapid Test, SARS-CoV-2 IgM Antibody Rapid Test |
| 00095295 | 2020-04-01 | Shanghai International Holding Corporation GmbH (Europe) | Zhuhai Livzon Diagnostics Inc. | China | HN: Livzon AP: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) |
| 00095256 | 2020-04-02 | MedNet EC-REP GmbH | 3D Biomedicine Science & Technology Co., Limited | China | HN: 3DMed 2019-nCoV RT-qPCR Detection Kit |
| 00095128 | 2020-04-02 | Shanghai International Holding Corporation GmbH (Europe) | Zybio Inc | China | HN: Zybio AP: SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) |
| 00095101 | 2020-04-02 | MedNet EC-REP GmbH | Jiangsu Bioperfectus Technologies Co., Ltd. | China | HN: COVID-19 Coronavirus Real Time PCR Kit, Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit, Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit AP: Corona Virus Test Kits |
| 00095086 | 2020-04-02 | Günter Keul GmbH | HN: Keul-o-test 2019-nCOV IgG/IgM-Schnelltestkassette AP: Coronavirus |
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| 00095405 | 2020-03-31 | Luxus Lebenswelt GmbH | Beijing Hotgen Biotech Co., Ltd | China | HN: Coronavirus disease(COVID-19) Antibody Test (Enzyme-Linked Immunosorbent Assay) AP: Coronavirus disease(COVID-19) Antibody Test (Enzyme-Linked Immunosorbent Assay) |
| 00095346 | 2021-01-07 | Medical Device Safety Service GmbH | Biomerica, Inc. | Vereinigte Staaten von Amerika | HN: COVID-19 IgG/IgM Rapid Test; COVID-19 IgG/IgM Rapid Strip Test; COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) |
| 00095167 | 2020-06-04 | Luxus Lebenswelt GmbH | BeiJing Abace Biotechnology Co., Ltd. | China | HN: COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold Immunochromatography) AP: COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold Immunochromatography) |
| 00095150 | 2020-03-31 | Luxus Lebenswelt GmbH | Beijing Hotgen Biotech Co., Ltd | China | HN: Coronavirus disease( COVID-19) Nucleic Acid Test Kit(PCR-Fluorescent Probe Method) AP: Coronavirus disease( COVID-19) Nucleic Acid Test Kit(PCR-Fluorescent Probe Method) |
| 00095149 | 2020-03-31 | Luxus Lebenswelt GmbH | Beijing Hotgen Biotech Co., Ltd | China | HN: Coronavirus disease( COVID-19) IgM/IgG Antibody Test (Enzyme-Linked Immunosorbent Assay) AP: Coronavirus disease( COVID-19) IgM/IgG Antibody Test (Enzyme-Linked Immunosorbent Assay) |
| 00095557 | 2020-04-02 | Osmunda Medical Technology Service GmbH | Foregene Co., Ltd. | China | HN: SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) |
| 00095028 | 2020-03-30 | Shanghai International Holding Corporation GmbH (Europe) | Zhejiang Orient Gene Biotech Co., Ltd | China | AP: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) |
| 00095545 | 2021-07-20 | Medical Technology Promedt Consulting GmbH | M monitor Inc. | Korea, Rep. | HN: Isopollo® COVID-19 detection kit (real-time); Isopollo® COVID-19 detection kit (premix); MmaxSure™ SARS-CoV-2 Detection Kit; MmaxSure™ EZ SARS-CoV-2 Detection Kit; MmaxSure™ COVID-19 detection kit (premix) |
| 00095490 | 2020-04-02 | Osmunda Medical Technology Service GmbH | Shaanxi Lifegen. Co., Ltd. | China | HN: Novel coronavirus (COVID-19) nucleic acid detection kit |
| 00095477 | 2020-04-02 | Osmunda Medical Technology Service GmbH | Beijing Jinwofu Bioengineering Technology Co.Ltd. | China | HN: Jinwofu® SARS-CoV-2 IgM/IgG Antibody Rapid Test AP: Jinwofu® Novel Coronavirus (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit |
| 00095475 | 2020-04-02 | Osmunda Medical Technology Service GmbH | Beijing Jinwofu Bioengineering Technology Co.,Ltd. | China | HN: Jinwofu® SARS-CoV-2 IgG Antibody Rapid Test AP: Jinwofu® Novel Coronavirus (SARS-CoV-2) IgG Antibody Rapid Test Kit |
| 00095452 | 2020-04-02 | Osmunda Medical Technology Service GmbH | Seinda Biomedical Corporation | China | HN: SARS-CoV-2 Antigen Test (CoVisAg) AP: SARS-CoV-2 Antigen Test (CoVisAg) |
| 00095440 | 2020-04-02 | Osmunda Medical Technology Service GmbH | Beijing Jinwofu Bioengineering Technology Co.,Ltd. | China | HN: Jinwofu® SARS-CoV-2 IgM Antibody Rapid Test AP: Jinwofu® Novel Coronavirus (SARS-CoV-2) IgM Antibody Rapid Test Kit |
| 00095427 | 2021-08-09 | Osmunda Medical Technology Service GmbH | Beijing Jinwofu Bioengineering Technology Co.,Ltd. | China | HN: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit AP: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit |
| 00095527 | 2021-01-15 | Medical Technology Promedt Consulting GmbH | Veredus Laboratories Pte Ltd | Singapur | HN: VereCoV™ Detection Kit; VereRT™ COVID-19 PCR Kit; VereRT™ ZeroPrep™ COVID-19 PCR Kit; VereCoV™ OneMix Detection Kit |
| 00095514 | 2021-05-11 | Medical Technology Promedt Consulting GmbH | NanoEnTek Inc. | Korea, Rep. | HN: FREND™ COVID-19 IgG/IgM Duo, FREND™ COVID-19 SP, FREND™ COVID-19 Ag, FREND™ COVID-19 total Ab; FREND™ COVID-19 Ag+FLU A&B AP: Different rapid qualitative and quantitative assays for severe acute respiratory syndrome coronavirus-2 |
| 00095418 | 2020-03-25 | Medical Device Safety Service GmbH | CTK Biotech, Inc. | Vereinigte Staaten von Amerika | HN: Aridia COVID-19 Real-Time PCR Test |
| 00095406 | 2020-06-04 | Luxus Lebenswelt GmbH | Beijing Hotgen Biotech Co., Ltd | China | HN: Novel Coronavirus 2019-nCoV Antibody Test (Up-converting Phosphor Immunochromatographic Technology) AP: Novel Coronavirus 2019-nCoV Antibody Test (Up-converting Phosphor Immunochromatographic Technology) |
| 00095404 | 2020-03-26 | Luxus Lebenswelt GmbH | Beijing Hotgen Biotech Co., Ltd | China | HN: Coronavirus disease(COVID-19) Antibody Test(Colloidal Gold) AP: Coronavirus disease(COVID-19) Antibody Test(Colloidal Gold) |
| 00095166 | 2020-03-25 | Luxus Lebenswelt GmbH | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. | China | HN: COVID-19(SARS-CoV-2) Antibody Test Kit(Colloidal Gold) AP: COVID-19(SARS-CoV-2) Antibody Test Kit(Colloidal Gold) |
| 00095138 | 2020-03-26 | Luxus Lebenswelt GmbH | Shanghai Realbio Technology Co. LTD | China | HN: 2019-novel coronavirus (2019-nCoV) Nucleic Acid Assay Kit (Fluorescence PCR Method) AP: 2019-novel coronavirus (2019-nCoV) Nucleic Acid Assay Kit (Fluorescence PCR Method) |
| 00095487 | 2020-11-04 | Medical Technology Promedt Consulting GmbH | Humasis Co., Ltd. | Korea, Rep. | HN: Humasis COVID-19 IgG/IgM Test; Humasis COVID-19 IgG/IgM Antibody Test; Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test; Humasis COVID-19 Ag Test; Celltrion DiaTrust™ COVID-19 Ag Rapid Test; Celltrion DiaTrust™ COVID-19/ Influenza Ag Duo Rapid Test; Humasis COVID-19/Flu Ag Combo Test |
| 00095471 | 2021-04-27 | Medical Technology Promedt Consulting GmbH | PaxGenBio Co., Ltd. | Korea, Rep. | HN: PaxView COVID-19 real-time RT-PCR Kit; PaxView SARS-CoV-2 MPCR-ULFA Kit; PaxView® SARS-CoV-2 real-time RT-PCR Kit |
| 00095456 | 2021-01-07 | Medical Device Safety Service GmbH | Quidel Corporation | Vereinigte Staaten von Amerika | HN: Lyra® SARS-CoV-2 Assay; Lyra® Direct SARS-CoV-2 Assay; Solana® SARS-CoV-2 Assay |
| 00095287 | 2021-08-09 | QIAGEN GmbH | HN: QIAstat-Dx Respiratory SARS-CoV-2 Panel AP: 691214 |
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| 00095142 | 2020-03-24 | Shanghai International Holding Corporation GmbH (Europe) | Hangzhou Clongene Biotech Co., Ltd. | China | HN: Clongene AP: COVID-19 IgG/IgM Rapid Test |
| 00095389 | 2020-04-15 | Medical Technology Promedt Consulting GmbH | Genomictree, Inc. | Korea, Rep. | HN: AccuraTect™ COVID-19 RT-qPCR Kit V1; AccuraDTect™ SARS-CoV-2 RT-qPCR Kit |
| 00095286 | 2020-03-23 | Prolinx GmbH | Zhuhai Encode Medical Engineering Co., Ltd. | China | AP: SARS-CoV-2 IgG/IgM Schnelltest |
| 00095321 | 2021-06-11 | Medical Technology Promedt Consulting GmbH | INVITES BIOCORE CO.LTD. | Korea, Rep. | HN: BioCore 2019-nCoV Real Time PCR Kit; AdvanSure™ COVID-19 real-time RT-PCR; BioCore COVID-19 Fast Real Time PCR Kit |
| 00095348 | 2021-08-16 | Medical Technology Promedt Consulting GmbH | BioMedomics, Inc. | Vereinigte Staaten von Amerika | HN: COVID-19 lgM-lgG Rapid Test; SARS-CoV-2 Antigen Test Kit (LFIA); CoV-SCAN Rapid Antigen Test |
| 00095347 | 2021-02-19 | Medical Technology Promedt Consulting GmbH | PCL. Inc. | Korea, Rep. | HN: PCLMD™ nCoV one step RT-PCR kit; PCL COVID19 Speedy RT-PCR; PCL 10min RNA Releasing Reagent; PCLMD ABC multi RT-PCR (Flu A/B + Covid-19); PCL RNA Extraction Kit |
| 00095345 | 2021-02-02 | Medical Technology Promedt Consulting GmbH | PCL. Inc. | Korea, Rep. | HN: PCL COVID19 Ag Rapid FIA; PCL COVID19 IgG/IgM Rapid Gold; PCL COVID19 Ag Gold |
| 00095192 | 2020-05-04 | gerbion GmbH & Co. KG | HN: virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 AP: G01128 |
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| 00095151 | 2020-03-19 | Luxus Lebenswelt GmbH | Beijing Hotgen Biotech Co., Ltd | China | HN: Coronavirus disease( COVID-19) IgM/IgG Antibody Test(Up-converting Phosphor Technology) AP: Coronavirus disease( COVID-19) IgM/IgG Antibody Test(Up-converting Phosphor Technology) |
| 00095148 | 2020-03-19 | Luxus Lebenswelt GmbH | Beijing Hotgen Biotech Co., Ltd | China | HN: Coronavirus disease( COVID-19) IgM/IgG Antibody Rapid Test(Colloidal Gold) AP: Coronavirus disease( COVID-19) IgM/IgG Antibody Rapid Test(Colloidal Gold) |
| 00095277 | 2020-08-20 | MP Biomedicals Germany GmbH | HN: 2019-nCoV IgG/IgM Combo Test Card | ||
| 00095212 | 2021-01-22 | Dr. Eberhard Spanuth Dianeering - Diagnostics Engineering & Research | Shanghai Kehua Bio-engineering Co., Ltd. | China | HN: Diagnostic kit for SARS-CoV-2 IgG Antibody (ELISA) |
| 00095208 | 2021-01-22 | Dr. Eberhard Spanuth Dianeering - Diagnostics Engineering & Research | Shanghai Kehua Bio-engineering Co., Ltd. | China | HN: Diagnostic kit for SARS-CoV-2 IgM Antibody (ELISA) |
| 00095156 | 2021-01-22 | Dr. Eberhard Spanuth Dianeering - Diagnostics Engineering & Research | Shanghai Kehua Bio-engineering Co., Ltd. | China | HN: Diagnostic Kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) AP: Diagnostic Kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) |
| 00095155 | 2021-01-22 | Dr. Eberhard Spanuth Dianeering - Diagnostics Engineering & Research | Shanghai Kehua Bio-engineering Co., Ltd. | China | HN: Diagnostic Kit for SARS-CoV-2 Nucleic Acid (Real-time PCR) AP: Diagnostic Kit for SARS-CoV-2 Nucleic Acid (Real-time PCR) |
| 00095040 | 2020-03-17 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: 2019-nCoV IgM (CLIA) |
| 00095039 | 2020-03-17 | Shanghai International Holding Corporation GmbH (Europe) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | China | HN: SNIBE AP: 2019-nCoV IgG (CLIA) |
| 00095275 | 2021-09-17 | Medical Technology Promedt Consulting GmbH | KH Medical Co., Ltd. | Korea, Rep. | HN: RADI COVID-19 Detection Kit; KH SARS-CoV-2 Detection Kit; RADI Flu-SC2 Detection Kit; CHAMP COVID-19 Multiplex Kit |
| 00095264 | 2021-08-11 | Medical Device Safety Service GmbH | CTK Biotech, Inc. | Vereinigte Staaten von Amerika | HN: OnSite COVID-19 IgG/IgM Rapid Test; Aria COVID-19 IgG/IgM Rapid Test; Answer COVID-19 IgG/IgM Rapid Test; SURGITECH COVID-19 IgG/IgM Rapid Test; Ad-bio COVID-19 IgG/IgM Rapid Test; OnSite COVID-19 Ag Rapid Test; Aria COVID-19 Ag Rapid Test; Answer COVID-19 Ag Rapid Test; ad-bio COVID-19 Ag Rapid Test; ImmuView COVID-19 Ag Rapid Test; SURGITECH COVID-19 Ag Rapid Test |
| 00095255 | 2020-05-07 | Medical Device Safety Service GmbH | DiaCarta, Inc. | Vereinigte Staaten von Amerika | HN: QuantiVirus™ Real-Time PCR Coronavirus (SARS- CoV-2) Detection Test; QuantiVirus™ SARS-CoV-2 Multiplex Detection Test |
| 00095134 | 2020-03-16 | Luxus Lebenswelt GmbH | Beijing Applied Biological Technologies Co., Ltd. | China | HN: Multiple Real-Time PCR Kit for Detection of 2019-nCoV AP: Multiple Real-Time PCR Kit for Detection of 2019-nCoV |
| 00095115 | 2020-03-16 | Luxus Lebenswelt GmbH | MABSKY BIO-TECH CO.,LTD | China | HN: Influenza A virus; Influenza B virus&COVID-19 virus(2019-nCoV) Triple-Detection Kit (Real-Time PCR Method) AP: Influenza A virus; Influenza B virus&COVID-19 virus(2019-nCoV) Triple-Detection Kit (Real-Time PCR Method) |
| 00095114 | 2020-03-16 | Luxus Lebenswelt GmbH | MABSKY BIO-TECH CO.,LTD | China | HN: COVID-19 virus(2019-nCoV) Triple-Detection Kit (Real-Time PCR Method) AP: COVID-19 virus(2019-nCoV) Triple-Detection Kit (Real-Time PCR Method) |
| 00095112 | 2020-03-16 | Luxus Lebenswelt GmbH | MABSKY BIO-TECH CO.,LTD | China | HN: COVID-19 virus(2019-nCoV) Dual-Detection Kit (Real-Time PCR Method) AP: COVID-19 virus(2019-nCoV) Dual-Detection Kit (Real-Time PCR Method) |
| 00095254 | 2020-03-13 | Roche Diagnostics GmbH | HN: SW cobas® SARS-CoV-2 ASAP cobas® 6800/8800 Systems | ||
| 00095253 | 2020-05-11 | Roche Diagnostics, GmbH | Roche Molecular Systems, Inc. | Vereinigte Staaten von Amerika | HN: cobas SARS-CoV-2, cobas SARS-CoV-2 Control Kit |
| 00095153 | 2021-03-12 | Medical Technology Promedt Consulting GmbH | Sugentech, Inc. | Korea, Rep. | HN: SGTi-flex COVID-19 IgG; SGTi-flex COVID-19 IgM; SGTi-flex COVID-19 IgM/IgG; SGTi-flex COVID-19 Ag; SGTi-flex COVID-19 & Flu A/B Ag DUO |
| 00095088 | 2020-10-20 | Servoprax GmbH | HN: Cleartest Corona AP: Cleartest Corona |
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| 00095098 | 2020-12-04 | Medical Technology Promedt Consulting GmbH | 1drop Inc. | Korea, Rep. | HN: 1copy™ COVID-19 qPCR Kit; 1copy™ COVID-19 qPCR Multi Kit; 1copy™ COVID-19 qPCR Triplex Kit; 1copy™ COVID-19 qPCR 4plex Kit |
| 00095092 | 2021-06-11 | Medical Technology Promedt Consulting GmbH | SD Biosensor, Inc. | Korea, Rep. | HN: STANDARD™ M nCoV Real-Time Detection kit; STANDARD™ F COVID-19 Ag FIA; STANDARD™ F COVID-19 IgM/IgG Duo FIA; STANDARD™ F COVID-19 IgM/IgG Combo FIA; STANDARD™ E COVID-19 Total Ab ELISA; STANDARD™ F COVID/Flu Ag Combo FIA; STANDARD™ M Flu/SARS-CoV-2 Real-Time Detection kit; STANDARD™ F SARS-CoV-2 nAb FIA; STANDARD™ M10 SARS-CoV-2 |
| 00095073 | 2020-02-26 | Luxus Lebenswelt GmbH | Wuhan HealthCare Biotechnology Co., Ltd. | China | HN: Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit AP: Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit |
| 00094937 | 2020-08-21 | TIB Molbiol Syntheselabor GmbH | HN: LightMix® Modular Sarbecovirus SARS-CoV-2 AP: 50-0776-96 |
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| 00094905 | 2021-07-09 | Medical Technology Promedt Consulting GmbH | GeneMatrix Inc. | Korea, Rep. | HN: NeoPlex™ GI-Virus 6 Detection Kit; NeoPlex™ COVID-19 Detection Kit; NeoPlex™ RV-Panel B Detection Kit; NeoPlex™ FluCOVID Detection Kit; NeoPlex™ COVID-19 FAST AP: Multiplex Real-time RT-PCR reagent |
| 00093963 | 2020-11-18 | MedNet GmbH | Trentron Biomedical Ltd. | Taiwan | HN: QubeMDx+ and VitaPCR AP: QubeMDx+ Instrument, VitaPCR Instrument |
| 00094167 | 2021-08-20 | MedNet GmbH | ACRO BIOTECH Inc. | Vereinigte Staaten von Amerika | AP: Control, COVID-19 Antigen Control |
| 00094374 | 2020-06-22 | Medical Technology Promedt Consulting GmbH | SD Biosensor Healthcare Pvt. Ltd. | Indien | HN: STANDARD Q Chikungunya lgM/IgG; STANDARD Q COVID-19 IgM/IgG Duo; STANDARD Q COVID-19 IgM/IgG Combo |
| 00093808 | 2020-10-28 | MIKROGEN GmbH | HN: Kontrollseren | ||
| 00093815 | 2021-05-31 | Medical Technology Promedt Consulting GmbH | Sugentech, Inc. | Korea, Rep. | HN: INCLIX™ PCT Control; INCLIX™ CRP Control; INCLIX™ HbA1c Control; INCLIX™ Total IgE Control; SGT i-flex Influenza Control; SGTi-flex COVID-19 Ag Control; INCLIX™ D-dimer Control |
| 00092781 | 2021-06-11 | Medical Technology Promedt Consulting GmbH | SD Biosensor, Inc. | Korea, Rep. | HN: STANDARD™ Influenza A/B Control, STANDARD™ Strep A Ag Control, STANDARD™ Legionella Ag Control, STANDARD™ S.pneumoniae Ag Control, STANDARD™ RSV Ag Control; STANDARD™ Dengue NS1 Ag control; STANDARD™ COVID-19 Ag Control; STANDARD™ COVID-19 IgM/IgG Control; SARS-CoV-2 Antigen Control; SARS-CoV-2 Antibody Control; STANDARD™ COVID-19 Ag Control swab; SARS-CoV-2 Antigen Control Swab; STANDARD™ COVID/Flu Ag Control Swab; STANDARD™ Dengue IgM/IgG Control |
| 00092249 | 2021-02-22 | Medical Technology Promedt Consulting GmbH | Medical Innovation Ventures Sdn. Bhd. | Malaysia | HN: GenoAmp® Bordetella pertussis Positive Control; GenoAmp® SARS-CoV-2 Positive Control; GenoAmp® Flu A/Flu B/SARS -CoV-2/MERS-CoV Positive Control; GenoAmp® COVID-19 Positive Control |
| 00092231 | 2021-02-02 | Medical Technology Promedt Consulting GmbH | GenBody Inc. | Korea, Rep. | HN: GenBody Influenza A/B Ag; GenBody Influenza A/B Ag Strip; GenBody FIA Influenza A/B Ag; GenBody Influenza/COVID-19 Ag Multi; GenBody Influenza/COVID-19 Ag Triple |
| 00092221 | 2021-06-01 | Medical Technology Promedt Consulting GmbH | GenBody Inc. | Korea, Rep. | HN: GenBody YFV IgG/IgM DUO; GenBody Chikungunya IgM; GenBody ZIKA IgG/IgM;GenBody ZIKA NS1 Ag;GenBody YFV IgG/IgM; GenBody YFV NS1 Ag; GenBody COVID-19 IgM/IgG; GenBody COVID-19 Ag; GenBody FIA COVID-19 Ag; GenBody Influenza/COVID-19 Ag Multi; iFinDx COVID-19 IgM/IgG; GenBody Influenza/COVID-19 Ag Triple; GenBody FIA COVID-19 NAb |
| 00091891 | 2020-10-23 | Medical Technology Promedt Consulting GmbH | GeneMatrix Inc. | Korea, Rep. | HN: NeoPlex™ RV-Flu/RSV Detection Kit; NeoPlex™ RV-Panel A Detection Kit; NeoPlex™ RV-Panel B Detection Kit; NeoPlex™ FluCOVID Detection Kit AP: Multiplex Real-time PCR reagent |
| 00091838 | 2021-02-09 | Medical Technology Promedt Consulting GmbH | Humasis Co., Ltd. | Korea, Rep. | HN: Humasis Influenza A/B Antigen Test(Influenza Test); Celltrion DiaTrust COVID-19 Ag Rapid Test; Celltrion DiaTrust COVID-19/ Influenza Ag Duo Rapid Test; Humasis COVID-19/Flu Ag Combo Test; Humasis Influenza Antigen Card plus (Influenza Test) |
| 00090665 | 2020-04-06 | MIKROGEN GmbH | HN: ampliCube Coronavirus Panel | ||
| 00089783 | 2021-03-12 | Medical Technology Promedt Consulting GmbH | Sugentech, Inc. | Korea, Rep. | HN: SGT i-flex Influenza A&B; SGTi-flex COVID-19 & Flu A/B Ag DUO |
| 00088523 | 2020-11-04 | Medical Technology Promedt Consulting GmbH | RapiGEN Inc. | Korea, Rep. | HN: BIOCREDIT RSV/Adeno + Influenza Duo; BIOCREDIT Influenza A&B Ag Quick Flu 3; BIOCREDIT Influenza A&B Ag; BIOCREDIT CoviFlu Ag Duo |
| 00087876 | 2020-04-27 | Medical Device Safety Service GmbH | WELLS BIO, INC. | Korea, Rep. | HN: careGENE™ Zika Virus RT-PCR kit; careGENE™ N-CoV RT-PCR kit; careGENE™ COVID-19 RT-PCR kit; BZ QPCR COVID-19 α kit |
| 00087772 | 2021-09-03 | Medical Technology Promedt Consulting GmbH | SpeeDx Pty Ltd. | Australien | HN: ResistancePlus® MG Analysis Software LC480; ResistancePlus® MG (7500); ResistancePlus® MG (LC480); PlexPCR® VHS (7500); PlexPCR® VHS (LC480); PlexPCR® VHS (CFX); PlexPCR® HV (7500); ResistancePlus® MG (CFX); ResistancePlus® GC (7500); ResistancePlus® GC (LC480); PlexPCR® RespiVirus (LC480); PlexPCR® RespiVirus (7500); ResistancePlus® GC (CFX); PlexPCR® HV (LC480); PlexPCR® HV (CFX); ResistancePlus® GC (z480); ResistancePlus® MG (z480); REFLEX ResistancePlus® MG (LC480); REFLEX ResistancePlus® MG (z480); PlexPCR® SARS-CoV-2 (LC480); PlexPCR® SARS-CoV-2 (CFX) |
| 00087630 | 2021-06-04 | Medical Technology Promedt Consulting GmbH | Medical Innovation Ventures Sdn. Bhd. | Malaysia | HN: ProDetect™ Zika lgG/lgM Rapid Test; ProDetect® COVID-19 IgG/IgM Rapid Test (Dipstick); ProDetect® COVID-19 IgG/IgM Rapid Test (Cassette); ProDetect® COVID-19 Antibody Rapid Test; ProDetect® COVID-19 Antigen Rapid Test; GenoAmp ® Real-Time RT-PCR COVID-19; ProDetect® COVID-19 Antigen Rapid Test (Oral Fluid) |
| 00087394 | 2020-10-02 | Medical Device Safety Service GmbH | AccuBioTech Co., Ltd. | China | HN: Accu-Tell® Rapid Chikungunya IgG/IgM Test; Accu-Tell® Rotavirus Test; Accu-Tell® Rotavirus/Adenovirus Test; Accu-Tell® Norovirus Test; ACCU-TELL® COVID-19 IgG/IgM Cassette; ACCU-TELL® SARS-CoV-2 Ag Cassette |
| 00087327 | 2020-05-27 | MedNet GmbH | ACRO BIOTECH Inc. | Vereinigte Staaten von Amerika | AP: Infection Disease Rapid Tests |
| 00086885 | 2021-01-04 | Immundiagnostik AG | HN: DrySpot-ID; PreventID SARS-CoV-2-Antikörper; Aportha Coronavirus-SARS-CoV-2-Antikörper AP: Trockenblutträger |
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| 00086980 | 2020-04-02 | Medical Technology Promedt Consulting GmbH | Medical Innovation Ventures Sdn. Bhd. | Malaysia | HN: GenoAmp® Real-Time RT-PCR MERS-CoV; GenoAmp® Real-Time RT-PCR Chiku; GenoAmp® Real-Time RT-PCR Dengue/Chiku Combo; GenoAmp® Real-Time RT-PCR Zika; GenoAmp® Trioplex Real-Time RT-PCR Zika/Den/Chiku; GenoAmp® Real-Time RT-PCR SARS-CoV-2; GenoAmp® Real-Time RT-PCR Flu A/Flu B/SARS-CoV-2/MERS-CoV |
| 00085825 | 2020-05-27 | MedNet GmbH | Hangzhou AllTest Biotech Co., Ltd. | China | AP: Infection Disease Rapid Tests |
| 00085684 | 2021-04-15 | Medical Technology Promedt Consulting GmbH | SD Biosensor, Inc. | Korea, Rep. | HN: STANDARD™ Q Ebola Zaire Ag; STANDARD™ Q MERS-CoV Ag Test; STANDARD™ Q Zika IgM/IgG Test; STANDARD™ Q Zika/Dengue Trio Test; STANDARD™ E Zika IgM ELISA; STANDARD™ Q Chikungunya IgM/IgG Test; STANDARD™ Q Dengue / Chikungunya Trio Test; STANDARD™ Q Zika / Dengue / Chikungunya Quad Test; STANDARD™ Q Zika IgM Test; STANDARD™ F Zika Ag FIA; STANDARD™ F Chikungunya lgM/lgG FIA; STANDARD™ F Zika IgM/IgG FIA;STANDARD™ Q Zika/Dengue IgM Duo Test; STANDARD™ F Zika IgM FIA; STANDARD™ Q Zika/Dengue Fast Trio Test; STANDARD™ Q ZIKV/DENV/CHIKV Fast Quad Test; STANDARD™ Q Yellow fever IgM Test; STANDARD™ Q Norovirus Ag Test; STANDARD™ F Zika/Dengue Ag Combo FIA; STANDARD™ Q Arbo Panel (Z/D/C/Y) Test; STANDARD™ F Norovirus Ag FIA; STANDARD™ Q COVID-19 IgM/IgG Duo Test; STANDARD™ Q COVID-19 Ag Test; STANDARD™ Q COVID-19 IgM/IgG Combo Test; STANDARD™ Q COVID-19 IgM/IgG Plus Test; STANDARD™ Q COVID-19 Ag/Ab Total Test; SARS-CoV-2 Rapid Antibody Test; SARS-CoV-2 Rapid Antigen Test; STANDARD™ Q COVID/Flu Ag Combo Test; SARS-CoV-2 Rapid Antigen Test Nasal; STANDARD™ Q COVID-19 Ag Saliva Test; STANDARD™ i-Q COVID-19 Ag Test; STANDARD™ Q COVID- 19 Ag Nasal Test |
| 00081846 | 2021-05-07 | Medical Technology Promedt Consulting GmbH | RapiGEN Inc. | Korea, Rep. | HN: BIOCREDIT Dengue IgG/IgM, BIOCREDIT Dengue NS1 Ag + Ab Duo, BIOCREDIT Dengue NS1 Ag, BIOCREDIT Malaria Ag Pan (pLDH), BIOCREDIT Malaria Ag Pf (HRP II), BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH), BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH), BIOCREDIT Malaria Ag Pf/Pv (HRPII/pLDH), BIOCREDIT Malaria Pf/Pv Ab, BIOCREDIT Chikungunya IgM; BIOCREDIT COVID-19 Ag; BIOCREDIT COVID-19 IgG+IgM Duo; BIOCREDIT COVID-19 IgG/IgM Combo; BIOCREDIT CoviFlu Ag Duo; BIOBEAT COVID-19 Ag Test; BIOCREDIT COVID-19 Ag Test Nasal; BIOCREDIT Malaria Ag Pf(pLDH); BIOCREDIT Malaria Ag Pf(pLDH/HRPII) |
| 00080945 | 2020-12-18 | Medical Technology Promedt Consulting GmbH | Solgent Co., Ltd. | Korea, Rep. | HN: DiaplexC™ RV13 Detection Kit; DiaPlexQ™ RV16 Detection Kit |
| 00080944 | 2020-12-18 | Medical Technology Promedt Consulting GmbH | Solgent Co., Ltd. | Korea, Rep. | HN: DiaplexC™ RV13 Detection Kit; DiaPlexQ™ RV16 Detection Kit |
| 00080943 | 2021-05-03 | Medical Technology Promedt Consulting GmbH | Solgent Co., Ltd. | Korea, Rep. | HN: DiaplexC™ RV13 Detection Kit; DiaPlexQ™ RV16 Detection Kit; DiaPlexQ™ Entero Virus Detection Kit |
| 00080942 | 2021-06-01 | Medical Technology Promedt Consulting GmbH | Solgent Co., Ltd. | Korea, Rep. | HN: DiaplexC™ RV13 Detection Kit; DiaPlexQ™ Ebola Virus Detection Kit- Zaire; DiaPlexQ™ RV16 Detection Kit; LytePrime™ Mplex ZCD RT-PCR Kit 1.0 (ZIKV/CHIKV/DENV); DiaPlexQ™ ZCD Detection Kit (ZIKV, CHIKV, DENV); DiaPlexQ™ Novel Corona Virus (2019-nCoV) Detection Kit; DiaPlexQ™ 2019-nCoV (RdRp, E, N) Detection Kit; DiaPlexQ™ COVID-19 (N,ORF1a) Detection Kit; DiaPlexQ™ Flu A/B & SARS-CoV-2 Detection Kit; DiaPlexQ™ SARS-CoV-2 Detection Kit |
| 00080008 | 2020-12-14 | Medical Technology Promedt Consulting GmbH | Solgent Co., Ltd. | Korea, Rep. | HN: DiaPlexC™ Influenza Virus A/B Detection Kit; DiaPlexC™ Influenza Virus A Subtype Detection Kit; DiaPlexQ™ Influenza Virus A Subtype Detection Kit; DiaPlexQ™ Influenza Virus A/B Detection Kit; DiaPlexC™ RV13 Detection Kit; DiaPlexQ™ RV16 Detection Kit; DiaPlexQ™ Flu A/B & SARS-CoV-2 Detection Kit |
| 00078954 | 2021-08-31 | Medical Device Safety Service GmbH | Daan Gene Co., Ltd. | China | HN: Norwalk Virus Fluorescent Polymerase Chain Reaction Diagnostic Kit; Rabies Virus Fluorescent Polymerase Chain Reaction Diagnostic Kit; Human Bocavirus Fluorescent Polymerase Chain Reaction Diagnostic Kit; Japanese Encephalitis Virus Fluorescent Polymerase Chain Reaction Diagnostic Kit; Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) |
| 00078748 | 2021-03-12 | Medical Technology Promedt Consulting GmbH | Rapid Pathogen Screening, Inc. | Vereinigte Staaten von Amerika | HN: FebriDx® |
| 00077075 | 2020-10-23 | Medical Technology Promedt Consulting GmbH | Bioneer Corporation | Korea, Rep. | HN: AccuPower® BKV Quantitative PCR Kit; AccuPower® Norovirus Real-Time RT-PCR Kit; AccuPower® STI 8B-Plex Real-Time PCR Kit; AccuPower® MERS-CoV (upE&ORF1a) Real-Time RT-PCR Kit; AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit; AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit; AccuPower® COVID-19 Real-Time RT-PCR Kit; AccuPower® SARS-CoV-2 Multiplex Real-Time RT-PCR Kit; AccuPower® COVID-19 Multiplex Real-Time RT-PCR Kit |
| 00065755 | 2021-06-04 | Medical Technology Promedt Consulting GmbH | Princeton BioMeditech Corporation | Vereinigte Staaten von Amerika | HN: BioSign® Flu A+B; Status® Flu A + B; ImmunoCardSTAT! ® Flu A&B; OSOM® Ultra Flu A&B; Status™ COVID-19/Flu; TekiTrust™ COVID-19/Flu A&B |
| 00055388 | 2021-09-01 | Medical Technology Promedt Consulting GmbH | Seegene Inc. | Korea, Rep. | HN: Allplex™ Respiratory Panel 2; Anyplex™ MERS-CoV (upE & orf1a) Real-time Detection; Allplex™ GI-Virus Assay; Allplex™ GI-Virus plus Assay; Seeplex® Meningitis ACE Detection (V2.0); Seeplex® Meningitis-B ACE Detection (V2.0); Seeplex® Meningitis-V1 ACE Detection (V2.0); Seeplex® Meningitis-V2 ACE Detection (V2.0); Allplex™ Meningitis-V1 Assay; Allplex™ Meningitis-V2 Assay; Allplex™ RV Essential Assay; Allplex™ Respiratory Panel 3; Allplex™2019-nCoV Assay; Allplex™ SARS-CoV-2 Assay; Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay; Allplex™ SARS-CoV-2 Master Assay; Allplex™ SARS-CoV-2 Variants I Assay; Allplex™ SARS-CoV-2 Variants II Assay |
| 00055387 | 2021-09-01 | Medical Technology Promedt Consulting GmbH | Seegene Inc. | Korea, Rep. | HN: Seeplex® RV15 ACE Detection; Anyplex™ II RV 16 Detection (V1.1); Seeplex® RV15 OneStep ACE Detection; Allplex™ Respiratory Panel 1; Allplex™ Respiratory Panel 1A; Allplex™ RV Essential Assay; Allplex™ SARS CoV 2 /FluA/FluB/RSV Assay |
| 00055384 | 2021-09-01 | Medical Technology Promedt Consulting GmbH | Seegene Inc. | Korea, Rep. | HN: Anyplex™FluA/B Typing Real-time Detection (V1.1); Allplex™ Respiratory Panel 1; Seeplex® RV15 ACE Detection; Anyplex™ II RV 16 Detection (V1.1); Seeplex® RV15 OneStep ACE Detection; Allplex™ Respiratory Panel 2; Allplex™ Respiratory Panel 1A; Allplex™ RV Essential Assay; Allplex™ SARS CoV 2 /FluA/FluB/RSV Assay |