Angezeigte Tests zum neuartigen Coronavirus (SARS-CoV-2) in Deutschland und Europa

Tests zur Detektion einer Infektion mit SARS-CoV-2 (neuartiges Coronavirus) sowie zum Nachweis von Antikörpern gehören zu den sog. In-vitro-Diagnostika (IVD). Das erstmalige Inverkehrbringen von In-vitro-Diagnostika auf dem deutschen Markt ist nach §§ 25 und 30 Medizinproduktegesetz (MPG) anzeigepflichtig. Das BfArM betreibt dafür die Datenbank "In-vitro-Diagnostika-Anzeigen (MPIVDA)", in welcher demnach auch Daten von "Corona-Tests" von den anzeigepflichtigen deutschen Herstellern und Bevollmächtigten bzw. Einführern erfasst werden.

Weitere Informationen zur allgemeinen Anzeigepflicht von In-vitro-Diagnostika finden Sie unter Anzeigen Medizinprodukte und In-vitro-Diagnostika.

Die EU-Kommission stellt Informationen zur Leistungsfähigkeit von Covid-19-Tests zur Verfügung:

COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Current performance of COVID-19 test methods and devices and proposed performance criteria - Working document of Commission services

Tabelle über In-vitro-Diagnostika zu SARS-CoV-2 in Deutschland

Nachfolgend finden Sie eine Übersicht formaler Daten der in Deutschland behördlich registrierten Tests auf SARS-CoV-2.
Es handelt sich um den Auszug eines Rechercheergebnisses der Datenbank MPIVDA mit Suchbegriffen, die das neuartige Coronavirus beschreiben. Alle Einträge in dieser Liste stehen in direktem Bezug zu SARS-CoV-2, auch wenn der eigentliche Begriff nicht in der Liste steht.
Als Suchbegriffe wurden herangezogen: "CoV-2", die synonyme Bezeichnung "nCoV" sowie die Bezeichnung der Krankheit "Covid-19".
Die Liste wird werktäglich aktualisiert. Sie ist nach dem Registrierdatum vorsortiert (chronologisch absteigend).

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

Bitte beachten Sie: Die nachfolgende 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 wurden 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.

* Anzeigepflichtig nach § 5 Medizinproduktegesetz (MPG) ist der Hersteller oder sein Bevollmächtigter bzw. Einführer.

Stand: 14.08.2020, Anzahl der Ergebnisse: 496

Dokument-nummer Registrier-datum Anzeigepflichtiger* in Deutschland Hersteller außerhalb Deutschlands Staat des Herstellers Handelsname (HN), Allgemeine Produktbezeichnung (AP)
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
00097015 2020-08-12 Intermundien-Lemon Europe GmbH DIOGENE Co.,Ltd. Korea, Rep. HN: DLPQ COVID19 Real Detection Kit
00096370 2020-08-12 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
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)
00096513 2020-08-11 JaviTech e.K. Genes Laboratories Korea, Rep. HN: NEXdia™ 2019-nCoV Detection Kit
AP: Novel Coronavirus detection kit
00097035 2020-08-11 KTR Europe GmbH BioPOA Co., Ltd. Korea, Rep. HN: Rapid COVID COVID-19 PoaCheck ™
00096593 2020-08-11 KTR Europe GmbH BIOWITHUS Inc. Korea, Rep. HN: INFINA™ 2019_nCoV Realt-time RT-PCR kit
AP: PCR Kit
00097013 2020-08-10 Medical Technology Promedt Consulting GmbH SG Medical Inc. Korea, Rep. HN: R-FIND COVID-19 IgG 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 2020-08-06 Medical Technology Promedt Consulting GmbH ProteomeTech Inc. Korea, Rep. HN: Product name: GENEdania, Model name: GENEdania COVID-19 qRT-PCR
00092221 2020-08-06 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; GenBody COVID-19 IgM/IgG Duo
00096913 2020-08-05 Intermundien-Lemon Europe GmbH WIZCHEM CO.,Ltd Korea, Rep. HN: COVICHEK
AP: Viral DNA/RNA Mini Prep Kit, Clinical Viral Transport Medium
00096718 2020-08-05 JaviTech e.K. PROTANBIO Inc. Korea, Rep. HN: PROTAN COVID-19 IgM/IgG
AP: Novel Coronavirus Antibody Rapid Test
00096925 2020-08-05 Medical Device Safety Service GmbH ACON Laboratories, Inc. Vereinigte Staaten von Amerika HN: Promotor® SARS-CoV-2 RT-PCR Test Kit
00096871 2020-08-05 MEDsan GmbH     HN: MEDsan COVID-19 IgM/IgG Rapid Test Hybrid
00096491 2020-08-03 BioCheck GmbH     HN: Polycheck® Virus Infection Serology
00096922 2020-08-03 Medical Technology Promedt Consulting GmbH General Biologicals Corporation Taiwan HN: GB SARS-CoV-2 Ab ELISA
00095098 2020-08-03 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
00087630 2020-08-03 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)
00080945 2020-08-03 Medical Technology Promedt Consulting GmbH Solgent Co., Ltd. Korea, Rep. HN: DiaplexC™ RV13 Detection Kit; DiaPlexQ™ RV16 Detection Kit
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
00096889 2020-08-03 Shanghai International Holding Corporation GmbH (Europe) Hangzhou Clongene Biotech Co., Ltd. China HN: Clongene
AP: COVID-19 Antigen Rapid Test
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)
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)
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)
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)
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)
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)
00095596 2020-07-28 Medical Device Safety Service GmbH BTNX, Inc. Kanada HN: Rapid Response™ COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma); Rapid Response™ Liberty COVID-19 IgG/IgM Test (Whole Blood/Serum/Plasma); Rapid Response™ COVID-19 Antigen Test Cassette
00080944 2020-07-28 Medical Technology Promedt Consulting GmbH Solgent Co., Ltd. Korea, Rep. HN: DiaplexC™ RV13 Detection Kit; DiaPlexQ™ RV16 Detection Kit
00096648 2020-07-27 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
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
00095487 2020-07-27 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
00081846 2020-07-27 Medical Technology Promedt Consulting GmbH RapiGEN Inc. Korea, Rep. HN: RapiGEN BIOCREDIT Dengue IgG/IgM, RapiGEN BIOCREDIT Dengue NS1 Ag + Ab Duo, RapiGEN BIOCREDIT Dengue NS1 Ag, RapiGEN BIOCREDIT Malaria Ag Pan (pLDH), RapiGEN BIOCREDIT Malaria Ag Pf (HRP II), RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH), RapiGEN BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH), RapiGEN BIOCREDIT Malaria Ag Pf/Pv (HRPII/pLDH), RapiGEN BIOCREDIT Malaria Pf/Pv Ab, RapiGEN BIOCREDIT Chikungunya IgM; BIOCREDIT COVID-19 Ag; BIOCREDIT COVID-19 IgG+IgM Duo; BIOCREDIT COVID-19 IgG/IgM Combo
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)
00095347 2020-07-24 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
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)
00096623 2020-07-22 EUROIMMUN Medizinische Labordiagnostika AG     AP: Anti-SARS-CoV-2-NCP-ELISA
00096650 2020-07-22 Europecert LP Diagnostic LLC Ukraine HN: VLM (Viral Lysis Medium)
AP: Abstrich- und Transportsystem
00096786 2020-07-22 Medical Technology Promedt Consulting GmbH Sanigen Co., Ltd. Korea, Rep. HN: Genelix™ COVID-19 Real-time PCR Kit
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)
00096611 2020-07-16 Aesku.Diagnostics GmbH & Co. KG     HN: AESKULISA SARS-CoV-2 NP IgM
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
00096091 2020-07-16 Caretechion GmbH Sophonix Co., Ltd. China HN: Severe Acute Respiratory Coronavirus 2 S1 Protein test kit (Magnetic particle chemiluminescence method)
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
00092231 2020-07-16 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
00096574 2020-07-15 Medical Device Safety Service GmbH DiaCarta, Inc. Vereinigte Staaten von Amerika HN: QuantiVirus™ Anti-SARS-CoV-2 IgG Test
00095879 2020-07-15 MedPath GmbH Sanming Bofeng Biotechnology Co.,Ltd China HN: Novel Coronavirus (SARS-CoV-2) Antibody IgM/IgG Kit (Colloidal Gold)
00095745 2020-07-14 MD-Clinicals ACCELERATE TECHNOLOG IES PTE. Singapur HN: Fortitude™ Kit 2.0
AP: COVID-19 Real-Time RT-PCR Test
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)
00093963 2020-07-14 MedNet GmbH Trentron Biomedical Ltd. Taiwan HN: QubeMDx+ and VitaPCR
AP: QubeMDx+ Instrument, VitaPCR Instrument
00096455 2020-07-14 MIKROGEN GmbH     HN: recomWell SARS-CoV-2 IgA
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)
00096526 2020-07-14 NIC GmbH Hangzhou Matridx Biotechnology Co., Ltd. China HN: SARS-CoV-2 Nucleic Acid Detection Kit (probe-based qRT-PCR)
AP: SARS-CoV-2 Nucleic Acid Detection Kit (probe-based qRT-PCR)
00096524 2020-07-10 Bioron Diagnostics GmbH     HN: RealLine SARS CoV-2 lyo (Str-format) VBD5580
00096563 2020-07-10 ScheBo Biotech AG     HN: ScheBo SARS-CoV-2 Antigen ELISA
00096581 2020-07-10 Vela Diagnostics Germany GmbH Vela Operations Singapore Pte Ltd Singapur HN: ViroKey™ SARS-CoV-2 RT-PCR Test v2.0
00096639 2020-07-09 jtc-diagnostics Pishtaz Teb Zaman Diagnostics Co. Iran, Islam. Rep. HN: SARS-CoV-2 IgM Capture ELISA
AP: IgM ELISA
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)
00085684 2020-07-09 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
00096169 2020-07-08 BIORON GmbH AO Vector-Best Russische Föderation HN: RealBest RNA SARS-CoV-2 , REF D-5580
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
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
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
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)
00096086 2020-07-07 MedPath GmbH Shanghai Personalbio Technology Co.,Ltd. China HN: SARS-CoV-2 nucleic acid detection kit (Quantitative fluorescence PCR)
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)
00096636 2020-07-06 Medical Technology Promedt Consulting GmbH ProteomeTech Inc. Korea, Rep. HN: Product name: KOVIcheck; Model name: KOVIcheck COVID-19 IgG/IgM
00096632 2020-07-06 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
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
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
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
00096103 2020-07-02 BIOTECON Diagnostics GmbH     HN: microproof® SARS-CoV-2 Screening Kit
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)
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)
00096495 2020-07-02 mdi Europa GmbH Excelsior-Biosystem Inc. Taiwan AP: OTHER OTHER VIROLOGY RAPID TESTS
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
00095153 2020-07-02 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
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)
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
00096304 2020-07-01 MedPath GmbH Shijiazhuang Lumitest Biotechnology Co.,Ltd China HN: COVID-19 IgG/IgM Rapid Test Kit
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)
00096083 2020-06-30 Bioron Diagnostics GmbH     HN: RealLine SARS-CoV-2 (A-Format BI1019-96; RealLine SARS-CoV-2 (B-format) BI1020-96
00096105 2020-06-30 BIOTECON Diagnostics GmbH     HN: microproof® SARS-CoV-2 Identification Kit
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
00096342 2020-06-30 MedNet EC-REP GmbH RayBiotech Inc. Guangzhou China AP: Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)
00096231 2020-06-30 MedNet GmbH Trentron Biomedical Ltd. Taiwan AP: VitaPCR SARS-CoV-2 Gen 2 Assay
00096232 2020-06-30 MedNet GmbH Trentron Biomedical Ltd. Taiwan HN: VitaPCR
AP: VitaPCR SARS-CoV-2 Gen 2 External Control Set
00096438 2020-06-29 mdi Europa GmbH Abnova (Taiwan) Corporation Taiwan AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION
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)
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)
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
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)
00096341 2020-06-25 MedNet EC-REP GmbH RayBiotech Inc. Guangzhou China AP: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)
00096418 2020-06-25 MedPath GmbH Sanming Bofeng Biotechnology Co.,Ltd China HN: Novel Coronavirus (SARS-CoV-2) Antibody Kit (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
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)
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
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
00096481 2020-06-22 AniCon Labor GmbH, Martin Liman, PhD     HN: Kylt® SARS-CoV-2 Complete RTU
00095264 2020-06-22 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
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
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
00096428 2020-06-19 DRG Instruments GmbH     HN: SARS-CoV-2 Antibody
00096512 2020-06-19 Intermundien-Lemon Europe GmbH FA INC Korea, Rep. HN: FTM (FA Transport Medium) / SDB VTM(SD Viral Transport Medium)
00096337 2020-06-18 mdi Europa GmbH Precision Biosensor Inc. Korea, Rep. AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION
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
00095527 2020-06-18 Medical Technology Promedt Consulting GmbH Veredus Laboratories Pte Ltd Singapur HN: VereCoV™ Detection Kit; VereRTCoV™ SARS-CoV-2 Real-Time RT-PCR 2.0
00095698 2020-06-18 MedNet EC-REP GmbH Shanghai Shenqi Biotechnology Co.,Ltd China AP: Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19
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
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
00096475 2020-06-12 Medical Technology Promedt Consulting GmbH Absology Co., Ltd. Korea, Rep. HN: Absoludy COVID-19 IgM/IgG Rapid; INIST COVID-19 lgM/lgG Rapid
00096355 2020-06-12 MedNet GmbH ACON Biotech (Hangzhou) Co., Ltd. China HN: Promotor
AP: SARS-COV-2 RT-PCR Test Kit
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
00096464 2020-06-10 BIOTECON Diagnostics GmbH Acumen Research Laboratories Pte Ltd Singapur HN: Acu-CoronaTM 2.0
00095244 2020-06-10 mölab GmbH     HN: mö-screen 2019-NCOV Corona Virus Test
00096410 2020-06-10 Pharma-Peter GmbH     HN: Covid-19 Canea Schnelltest
AP: Covid-19 IgM/IgG Ab Schnelltest
00096076 2020-06-09 Caretechion GmbH MEIZHOU CORNLEY® HI-TECH CO.,LTD China HN: COVID-19 IgG/IgM Detection Kit(Colloidal Gold)
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)
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
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
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)
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)
00095092 2020-06-09 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
00094905 2020-06-09 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
AP: Multiplex Real-time RT-PCR reagent
00096111 2020-06-09 MedNet GmbH MedMira Inc. Kanada HN: REVEALCOVID-19 (TM) Total Antibody Test
00095703 2020-06-09 Vela Diagnostics Germany GmbH Vela Operations Singapore Pte Ltd Singapur HN: ViroKey SARS-CoV-2 RT-PCR 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
00096255 2020-06-08 HUMAN Gesellschaft für Biochemica und Diagnostica mbH HUMAN Diagnostics Product (Beijing) Co.,Ltd. China HN: HEXAGON SARS-CoV-2 IgM-IgG
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 2020-06-08 Medical Technology Promedt Consulting GmbH BioNote, Inc. Korea, Rep. HN: NowCheck COVID-19 Ag Test; NowCheck COVID-19 IgM/IgG Test
00096349 2020-06-08 NanoRepro AG InTec PRODUCTS, INC. China HN: SARS-CoV-2 Antikörper-Schnelltest (IgM/IgG)
00096047 2020-06-08 Shanghai International Holding Corporation GmbH (Europe) SUZHOU HYBIOME BIOMEDICAL ENGINEERING CO., LTD China HN: HYBIOME
AP: SARS-CoV-2 IgM (Chemiluminescent Immunoassay)
00096046 2020-06-08 Shanghai International Holding Corporation GmbH (Europe) SUZHOU HYBIOME BIOMEDICAL ENGINEERING CO., LTD China HN: HYBIOME
AP: SARS-CoV-2 IgG (Chemiluminescent Immunoassay)
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
00096335 2020-06-05 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
00095765 2020-06-04 BerkeMed GmbH Wuhan Considerin Gene&Health 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)
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)
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)
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)
00096401 2020-06-04 Medical Technology Promedt Consulting GmbH OPTI Medical Systems, Inc. Vereinigte Staaten von Amerika HN: OPTI SARS-CoV-2 RT-PCR Test
00096071 2020-06-04 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)
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)
00096371 2020-06-03 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
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
00095937 2020-06-02 Medical Device Safety Service GmbH MiRXES Pte Ltd Singapur HN: MiRXES Fortitude Kit 2.0E; MiRXES Fortitude Kit 2.1
00096399 2020-06-02 Medical Technology Promedt Consulting GmbH Wizbiosolutions Inc. Korea, Rep. HN: WizDx™ COVID-19 CrystalMix PCR Kit; WizDx™ COVID-19 Real-time 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 2020-05-29 Medical Technology Promedt Consulting GmbH PRIME4DIA Co., Ltd. Korea, Rep. HN: P4DETECT COVID-19 IgM/IgG
AP: Rapid test for determination of COVID-19 IgM/IgG
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
00095091 2020-05-29 PharmACT AG     HN: CoV-2 RAPID TEST
AP: SARS-CoV-2 (Coronavirus Disease 2019) IgM / IgG Antibody Detection Reagent Kit
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
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
00095842 2020-05-28 BerkeMed GmbH Shenzhen HYK Gene 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)
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)
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
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)
00095434 2020-05-28 Luxus Lebenswelt GmbH JIANGSU DABO 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 2020-05-28 Luxus Lebenswelt GmbH JIANGSU DABO 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 2020-05-28 Luxus Lebenswelt GmbH JIANGSU DABO 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)
00096375 2020-05-28 Medical Technology Promedt Consulting GmbH SLSBio Co. Ltd. Korea, Rep. HN: SsmarTest COVID-19 IgM/IgG Detection Kit (Model name: huCOVID19-01)
00096066 2020-05-28 R-Biopharm AG     HN: RIDA®GENE SARS-CoV-2
00096361 2020-05-28 Roche Diagnostics GmbH     HN: PreciControl Anti-SARS-CoV-2
00087327 2020-05-27 MedNet GmbH ACRO BIOTECH Inc. Vereinigte Staaten von Amerika AP: Infection Disease Rapid Tests
00085825 2020-05-27 MedNet GmbH Hangzhou AllTest Biotech Co., Ltd. China AP: Infection Disease Rapid Tests
00095671 2020-05-26 Caretechion GmbH GUANGDONG ARDENT BIOMED Co., Ltd. China HN: Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (PCR-fluorescent Probe)
00095903 2020-05-26 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
00077075 2020-05-26 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
00095950 2020-05-26 MedNet EC-REP GmbH Qingdao Hightop Biotech Co., Ltd. China HN: Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Dual fluorescence RT-PCR)
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)
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
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
00095470 2020-05-25 MedPath GmbH Shenzhen Haisian Biotech Co., Ltd China HN: COVID-19 IgM/IgG Combo Rapid Test
00096302 2020-05-22 Medical Technology Promedt Consulting GmbH B-bio Co., Ltd. Korea, Rep. HN: ChekR™ COVID-19 IgM/IgG Rapid test
AP: COVID-19 IgM/IgG Rapid test
00096299 2020-05-22 Medical Technology Promedt Consulting GmbH Jei Daniel (JD) Biotech Corp. China HN: JDBIOTECH New Coronavirus IgG/IgM Rapid Test Kit (COVID-19 IgG/ IgM)
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
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
00096166 2020-05-19 LIONEX GmbH     HN: COVID-19 ELISA – Human IgG
AP: COVID-19 ELISA – Human IgG
00095283 2020-05-19 MedPath GmbH Shanghai Outdo Biotech Co., Ltd. China HN: Novel Coronavirus (SARS-CoV-2) Antibody (IgM/IgG) Test
00096132 2020-05-18 Medical Device Safety Service GmbH IMMY, Inc. Vereinigte Staaten von Amerika HN: clarus SARS-CoV-2 Total Antibody EIA
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
00096013 2020-05-15 Bosch Healthcare Solutions GmbH     HN: Vivalytic VRI
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)
00096075 2020-05-15 mdi Europa GmbH Nano-Ditech Corporation Vereinigte Staaten von Amerika AP: OTHER VIRAL ANTIGEN/ANTIBODY DETECTION
00095882 2020-05-15 mdi Europa GmbH GeneReach Biotechnology Corporation Taiwan AP: Other Virology - NA Reagents
00096186 2020-05-15 Medical Device Safety Service GmbH WELLS BIO, INC. Korea, Rep. HN: careUS™ COVID-19 IgM / IgG
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
00095392 2020-05-15 MedNet GmbH Beijing Diagreat Biotechnologies Co., Ltd China HN: 2019-nCoV specific test
00095071 2020-05-15 MedNet GmbH Beijing Diagreat Biotechnologies Co., Ltd China HN: 2019-nCoV specific test
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)
00095697 2020-05-15 MedPath GmbH Tianjin GensKey Medical Technology Co., Ltd. China HN: GensKey SARS-CoV-2 Analysis Software
00096065 2020-05-15 NovaTec Immundiagnostica GmbH     HN: NovaPrime
AP: 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
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)
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
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
00095860 2020-05-14 MedNet EC-REP GmbH Artron Laboratories Inc. Kanada AP: COVID-19 IgM/IgG Antibody Test
00095107 2020-05-14 MedPath GmbH Shanghai Focusgen Biotechnology Limited Company China HN: Novel coronavirus (2019-nCoV) Real-time PCR kit
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
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
00096127 2020-05-12 LDN Labor Diagnostika Nord GmbH & Co KG     HN: COVID 19 (SARS-CoV-2) IgM ELISA
00096126 2020-05-12 LDN Labor Diagnostika Nord GmbH & Co KG     HN: COVID 19 (SARS-CoV-2) IgG ELISA
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)
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)
00096040 2020-05-11 EUROIMMUN Medizinische Labordiagnostika AG     AP: Anti-SARS-CoV-2-NCP-ELISA
00096084 2020-05-11 HAIN LIFESCIENCE GmbH     HN: FluoroType® SARS-CoV-2 plus VER 1.0
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
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)
00096081 2020-05-08 Medical Device Safety Service GmbH Access Bio, Inc. Vereinigte Staaten von Amerika HN: CareStart™ COVID-19 IgM/IgG
00095346 2020-05-07 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
00095456 2020-05-07 Medical Device Safety Service GmbH Quidel Corporation Vereinigte Staaten von Amerika HN: Lyra® SARS-CoV-2 Assay; Lyra® Direct SARS-CoV-2 Assay
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
00080942 2020-05-07 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
00095719 2020-05-07 MIKROGEN GmbH     HN: ampliCube Coronavirus SARS-CoV-2
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)
00095863 2020-05-06 Demeditec Diagnostics GmbH     AP: COVID-19 (SARS-CoV-2)
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)
00095588 2020-05-06 MedNet EC-REP GmbH Beijing Beier Bioengineering Co., Ltd China AP: 2019-New Coronavirus IgM Rapid Test Cassette (WB/S/P)
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)
00096073 2020-05-06 MIKROGEN GmbH     HN: recomWell SARS-CoV-2 IgG
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)
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)
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
00095398 2020-05-05 AniCon Labor GmbH, Martin Liman, PhD     HN: Kylt® SARS-CoV-2 Confirmation RTU
00095397 2020-05-05 AniCon Labor GmbH, Martin Liman, PhD     HN: Kylt® SARS-CoV-2 Screening RTU
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)
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
00095476 2020-05-05 Shanghai International Holding Corporation GmbH (Europe) Zhuhai Livzon Diagnostics Inc. China HN: Livzon
AP: Livzon SARS-CoV-2 RT-PCR Kit
00095473 2020-05-05 Shanghai International Holding Corporation GmbH (Europe) Dongguan Bosh Biotechnologies, Ltd. China HN: Bosh
AP: SARS-CoV-2 IgM & IgG Rapid Test
00095192 2020-05-04 gerbion GmbH & Co. KG     HN: virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0
AP: G01128
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
00095975 2020-05-04 MedNet GmbH ACON Biotech (Hangzhou) Co., Ltd. China HN: ACON; Quik-Check
AP: SARS-CoV-2 IgG/IgM Rapid Test
00096002 2020-05-04 Roche Diagnostics GmbH     HN: Elecsys Anti-SARS-CoV-2
00095972 2020-04-30 altona Diagnostics GmbH     HN: RealStar SARS-CoV-2 RT-PCR Kit 1.0
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)
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)
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
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
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
00095810 2020-04-30 Pharmact GmbH     HN: BelTEST It ! SARS-CoV-2 specific IgM / IgG
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)
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)
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 2020-04-29 Shanghai International Holding Corporation GmbH (Europe) Hecin Scientific Inc. China HN: Hecin
AP: COVID-19 Real-time PCR Assay Kit
00095318 2020-04-29 Shanghai International Holding Corporation GmbH (Europe) Hecin Scientific Inc. China HN: Hecin
AP: COVID-19 IgM Antibody Rapid Test Kit
00095111 2020-04-29 Shanghai International Holding Corporation GmbH (Europe) Zhuhai Livzon Diagnostics Inc. China HN: Livzon
AP: Diagnostic Kit for IgM Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)
00095110 2020-04-29 Shanghai International Holding Corporation GmbH (Europe) Zhuhai Livzon Diagnostics Inc. China HN: Livzon
AP: Diagnostic Kit for IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)
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)
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)
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
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 2020-04-27 JaviTech e.K. Genesystem Co., Ltd. Korea, Rep. HN: SMARTCHEK®
AP: Gene analysis reagent for in-vitro Diagnostic Device
00095812 2020-04-27 Medical Device Safety Service GmbH PlexBio Co., Ltd. Taiwan HN: IntelliPlex SARS-CoV-2 Detection Kit
00095809 2020-04-27 Medical Device Safety Service GmbH Access Bio, Inc. Vereinigte Staaten von Amerika HN: CareStart™ COVID-19 MDx RT-PCR
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
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 2020-04-23 Medical Technology Promedt Consulting GmbH Asan Pharmaceutical Co., Ltd. Korea, Rep. HN: Asan Easy Test® COVID-19 IgG/IgM
00095684 2020-04-22 ScheBo Biotech AG     HN: ScheBo SARS-CoV-2 Quick
AP: SARS-CoV-2 IgG/IgM Antibody Test Kit
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)
00095790 2020-04-21 mdi Europa GmbH Schweitzer Biotech Company Ltd. Taiwan AP: SBC SARS-CoV-2 qPCR Kit
00095789 2020-04-21 mdi Europa GmbH Medigen Vaccine Biologics Corp. Taiwan AP: OTHER OTHER GENETIC TESTS
00095850 2020-04-21 Medical Technology Promedt Consulting GmbH General Biologicals Corporation Taiwan HN: GB SARS-CoV-2 Real- Time RT-PCR
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
00055388 2020-04-16 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
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
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)
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
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)
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
00095712 2020-04-08 Medical Technology Promedt Consulting GmbH GeneOne Diagnostic Corporation Taiwan HN: GeneOne COVID-19 Nucleic Acid Diagnostic Kit
00095321 2020-04-08 Medical Technology Promedt Consulting GmbH BioCore Co.Ltd. Korea, Rep. HN: BioCore 2019-nCoV Real Time PCR Kit; AdvanSure™ COVID-19 real-time RT-PCR
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
00095226 2020-04-07 MedNet EC-REP GmbH Wuhan EasyDiagnosis Biomedicine Co., Ltd. China AP: COVID-19 (SARS-CoV-2) nucleic acid 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
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
00095309 2020-04-06 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
00090665 2020-04-06 MIKROGEN GmbH     HN: ampliCube Coronavirus Panel
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)
00095124 2020-04-06 Shanghai International Holding Corporation GmbH (Europe) Maccura Biotechnology Co., Ltd. China HN: Maccura
AP: SARS-CoV-2 Fluorescent PCR
00095667 2020-04-03 Medical Technology Promedt Consulting GmbH OPTOLANE Technologies, Inc. Korea, Rep. HN: Kaira 2019-nCoV Detection Kit
00095137 2020-04-03 nal von minden GmbH     AP: COVID-19 lgG/lgM Test
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
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)
00095086 2020-04-02 Günter Keul GmbH     HN: Keul-o-test 2019-nCOV IgG/IgM-Schnelltestkassette
AP: Coronavirus
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
00092249 2020-04-02 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
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
00095256 2020-04-02 MedNet EC-REP GmbH 3D Biomedicine Science & Technology Co., Limited China HN: 3DMed 2019-nCoV RT-qPCR Detection Kit
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
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)
00095551 2020-04-02 Osmunda Medical Technology Service GmbH RayBiotech Life, Inc. Vereinigte Staaten von Amerika HN: Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)
00095538 2020-04-02 Osmunda Medical Technology Service GmbH RayBiotech Life, Inc. Vereinigte Staaten von Amerika HN: Novel Coronavirus (SARS-CoV-2) IgM antibody detection kit (colloidal gold method)
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 2020-04-02 Osmunda Medical Technology Service GmbH Beijing Jinwofu Bioengineering Technology Co.,Ltd. China HN: Jinwofu®(SARS-CoV-2) Antigen Rapid Test
AP: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit
00095331 2020-04-02 Osmunda Medical Technology Service GmbH Guangzhou Tebsun Bio-Tech Development Co., LTD China HN: SARS-CoV-2 Nucleic Acid Test
00095328 2020-04-02 Osmunda Medical Technology Service GmbH Guangzhou Tebsun Bio-Tech Development Co., LTD China HN: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Immunochromatographic Assay)
00095301 2020-04-02 Osmunda Medical Technology Service GmbH Zhejiang Gene Science Co.,Ltd. China HN: Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography)
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)
00095410 2020-04-01 EUROIMMUN Medizinische Labordiagnostika AG     AP: Anti-SARS-CoV-2-ELISA
00095633 2020-04-01 Medical Technology Promedt Consulting GmbH Diagnostics for the Real World, Ltd. Vereinigte Staaten von Amerika HN: SAMBA II SARS-CoV-2 Test
00095595 2020-04-01 Medical Technology Promedt Consulting GmbH Biolidics Ltd Singapur HN: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)
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)
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)
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)
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)
00092781 2020-03-31 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™Q COVID-19 Ag Control; STANDARD™ COVID 19 IgM/IgG Control
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 2020-03-27 Medical Technology Promedt Consulting GmbH M monitor Inc. Korea, Rep. HN: Isopollo® COVID-19 detection kit (real-time); Isopollo® COVID-19 detection kit (premix)
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)
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)
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)
00095418 2020-03-25 Medical Device Safety Service GmbH CTK Biotech, Inc. Vereinigte Staaten von Amerika HN: Aridia COVID-19 Real-Time PCR Test
00095514 2020-03-25 Medical Technology Promedt Consulting GmbH NanoEnTek Inc. Korea, Rep. HN: FREND™ COVID-19 IgG/IgM Duo
AP: Rapid qualitative assay for severe acute respiratory syndrome coronavirus-2
00095471 2020-03-24 Medical Technology Promedt Consulting GmbH PaxGenBio Co., Ltd. Korea, Rep. HN: PaxView COVID-19 real-time RT-PCR Kit
00095287 2020-03-24 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
00095286 2020-03-23 Prolinx GmbH Zhuhai Encode Medical Engineering Co., Ltd. China AP: SARS-CoV-2 IgG/IgM Schnelltest
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)
00095348 2020-03-19 Medical Technology Promedt Consulting GmbH BioMedomics, Inc. Vereinigte Staaten von Amerika HN: COVID-19 lgM-lgG Rapid Test
00095345 2020-03-19 Medical Technology Promedt Consulting GmbH PCL. Inc. Korea, Rep. HN: PCL COVID19 Ag Rapid FIA; PCL COVID19 IgG/IgM Rapid Gold
00095277 2020-03-17 MP Biomedicals Germany GmbH     HN: 2019-nCoV IgG/IgM Combo Test
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)
00095212 2020-03-16 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 2020-03-16 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 2020-03-16 Dr. Eberhard Spanuth Dianeering - Diagnostics Engineering & Research Shanghai Kehua Bio-engineering Co., Ltd. China HN: Diagnostic kit for SARS-CoV-2 IgG/IgM Antibody (Colloidal Gold)
AP: SARS-CoV-2 IgG/IgM Antibody
00095155 2020-03-16 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: Real Time PCR
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)
00095275 2020-03-16 Medical Technology Promedt Consulting GmbH KH Medical Co., Ltd. Korea, Rep. HN: RADI COVID-19 Detection Kit
00095254 2020-03-13 Roche Diagnostics GmbH     HN: SW cobas® SARS-CoV-2 ASAP cobas® 6800/8800 Systems
00095088 2020-03-11 Servoprax GmbH     HN: Cleartest Corona
AP: Cleartest Corona
00087394 2020-03-10 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
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
00078954 2020-02-04 Medical Device Safety Service GmbH Da An Gene Co., Ltd. of Sun Yat-sen University 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)

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