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:

Recherche in öffentlichen Medizinprodukte-Datenbanken

* 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
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
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
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
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
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
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
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
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
00100513 2021-06-29 NanoRepro AG     HN: NanoRepro SARS-CoV-2 Antigen Schnelltest
AP: SARS-CoV-2 Antigen Schnelltest
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
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
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
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
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
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
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
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
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
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
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
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
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.
00099803 2021-04-12 Bio-Gram Diagnostics Germany     HN: COVID-19 Ag Test Kit
AP: Covid-19 Antigen Schnelltest für Laien
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
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
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
00099629 2021-03-25 OFM GmbH     HN: Deni COVID-19 Antigen Test
AP: Antigen Selbsttest
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
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
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
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
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
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
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
00099345 2021-03-12 gerbion GmbH & Co. KG     HN: respiraScreen 2 real time RT-PCR Kit
AP: G01131
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)
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
00099220 2021-02-18 Pharmact GmbH     HN: BELTEST-IT AGS
AP: COVID-19 Antigen-Schnelltest (Latex)
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
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
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
00098242 2020-12-10 nal von minden GmbH     HN: dedicio® COVID-19 Ag plus Test
AP: Covid-19 Ag Test
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
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
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
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
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
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
00096595 2020-07-08 DiaMex GmbH     HN: Optitrol COVID-19 G
AP: Optitrol COVID-19 G
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
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
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
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
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)
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
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
00095802 2020-04-30 NovaTec Immundiagnostica GmbH     HN: NovaLisa
AP: SARS-CoV-2 (COVID-19) IgA
00095801 2020-04-30 NovaTec Immundiagnostica GmbH     HN: NovaLisa
AP: SARS-CoV-2 (COVID-19) IgG
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
00095787 2020-04-27 GA Generic Assays GmbH     HN: GA CoV-2 IgM
AP: 3930
00095786 2020-04-27 GA Generic Assays GmbH     HN: GA CoV-2 IgG
AP: 3920
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
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
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
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
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
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
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
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

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