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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

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437 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: GenaBio Diagnostics Inc. Commercial: GenaBio SARS-CoV-2 Antigen Lateral Flow Test Device ID: 1585 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenBody, Inc Commercial: Genbody COVID-19 Ag Test Device ID: 1244 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenBody, Inc Commercial: GenBody FIA COVID-19 Ag Device ID: 1297 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Green Cross Medical Science Corp. Commercial: GENEDIA W COVID-19 Ag Device ID: 1144 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: OSANG Healthcare Co., Ltd Commercial: GeneFinder COVID-19 Ag Rapid Test Device ID: 1593 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenSure Biotech Inc Commercial: GenSure COVID-19 Antigen Rapid Kit Device ID: 1253 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Philosys Co., Ltd. Commercial: Gmate® COVID-19 Ag Device ID: 1611 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Humasis Commercial: Humasis COVID-19 Ag Test Device ID: 1263 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Humasis Commercial: Humasis COVID-19/Flu Ag Combo Test Device ID: 1262 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Innovative Diagnostics Commercial: iD Rapid® COVID-19 Antigen Device ID: 1728 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Metas Biomedical Inc. Commercial: ImmTek COVID-19 Antigen Rapid Test Device ID: 1928 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Nantong Diagnos Biotechnology Co., Ltd Commercial: Influenza A+B Antigen Test Kit (Colloidal Gold) Device ID: 1301 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Innova Medical Group, Inc. Commercial: Innova SARS CoV-2 Antigen Rapid Qualitative Test Device ID: 1801 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Vitrosens Biotechnology Co., Ltd Commercial: Instant SARS-CoV-2 Rapid Ag Test Device ID: 1444 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Alfa Scientific Designs Inc Commercial: Instant-view® PLUS COVID-19 Antigen Test Device ID: 1678 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Jinwofu Bioengineering Technology Co.,Ltd Commercial: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test Device ID: 1725 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Device ID: 1284 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 Antigen Rapid Test Kit (FIA) Device ID: 70 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) Device ID: 1285 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Zhejiang Quark Biotechnology Co., Ltd Commercial: Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces) Device ID: 1322 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BMT Diagnostics Commercial: Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab) Device ID: 1605 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shanghai Liangrun Biomedicine Technology Co.,Ltd. Commercial: LionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay) Device ID: 2155 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Zhuhai Livzon Diagnostics Inc Commercial: Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow) Device ID: 1441 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Zhuhai Livzon Diagnostics Inc Commercial: Livzon Test for SARS-CoV-2 Antigen (Fluorescence Immunochromatographic Assay) Device ID: 1442 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: LumiraDX Commercial: LumiraDx SARS-CoV-2 Ag Test Device ID: 1268 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Laihe Biotech Co., Ltd Commercial: LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) Device ID: 1215 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: ArcDia International Ltd Commercial: mariPOC SARS-CoV-2 Device ID: 768 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BBB Inc. Commercial: MARK-B COVID-19 Ag Device ID: 2315 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Wuhan NanoDiagnosis for Health Biotechnology Co., Ltd Commercial: Mednano Device ID: 1749 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEDsan GmbH Commercial: MEDsan SARS-CoV-2 Antigen Rapid Test Device ID: 1180 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEXACARE GmbH Commercial: MEXACARE COVID-19 Antigen Rapid Test Device ID: 1775 Method: Chromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: möLab Commercial: mö-screen Corona Antigen Test Device ID: 1190 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd Commercial: Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19) Device ID: 1490 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Nal von minden GmbH Commercial: NADAL COVID-19 Ag Test Device ID: 1162 Method: Chromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: NG Biotech Commercial: NG-Test SARS-CoV-2 Ag Device ID: 1646 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: NG Biotech Commercial: Ninonasal Device ID: 1880 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: NG Biotech Commercial: Ninonasal-Autotest Device ID: 2281 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Chongqing Novegent Biotech Company Limited Commercial: Novegent COVID-19 Antigen Rapid Test Kit Device ID: 1189 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing WSWY Technology Co.,.Ltd Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography) Device ID: 1362 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography) Device ID: 1795 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Nanjing Norman Biological Technology Co.,Ltd Commercial: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) Device ID: 2506 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Medakit Ltd Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) Device ID: 1784 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BN Santé Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) Device ID: 1828 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen rapid test Device ID: 1743 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) Device ID: 1220 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Innovation Biotech (Beijing) Co.,ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) Device ID: 2278 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) Device ID: 2018 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) Device ID: 1796 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Jinwofu Bioengineering Technology Co.,Ltd. Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit Device ID: 2072 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co., Ltd Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) Device ID: 1870 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements