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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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163 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: DIALAB GmbH Commercial: DIAQUICK COVID-19 Ag Cassette Device ID: 1375 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: DiaSorin S.p.A Commercial: LIAISON® SARS-CoV-2 Ag Device ID: 1960 Method: CLIA Target: Antigen Format: Automated, Lab-based Go to details
CE Marking: Yes Manufacturer: DNA Diagnostic Commercial: COVID-19 Antigen Detection Kit Device ID: 2242 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Dräger Safety AG & Co. KGaA Commercial: Dräger Antigen Test SARS-CoV-2 Device ID: 2273 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Dynamiker Biotechnology(Tianjin) Co., Ltd. Commercial: Dynamiker SARS-CoV-2 Ag Rapid Test Device ID: 2533 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Edinburgh Genetics Limited Commercial: ActivXpress+ COVID-19 Antigen Complete Testing Kit Device ID: 1243 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Eurobio Scientific Commercial: EBS SARS-CoV-2 Ag Rapid Test Device ID: 1739 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Fujirebio Commercial: ESPLINE SARS-CoV-2 Device ID: 2147 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GA Generic Assays GmbH Commercial: GA CoV-2 Antigen Rapid Test Device ID: 1855 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: GenBody, Inc Commercial: GenBody COVID-19 Ag Device ID: 1244 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Genrui Biotech Inc Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Device ID: 2012 Method: Immunochromatography 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: Getein Biotech, Inc Commercial: SARS-CoV-2 Antigen (Colloidal Gold) Device ID: 1820 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Getein Biotech, Inc. Commercial: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) Device ID: 2183 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Goldsite Diagnostics Inc Commercial: SARS-CoV-2 Antigen Kit (Colloidal Gold) Device ID: 1197 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: Guangdong Hecin Scientific, Inc. Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) Device ID: 1747 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangdong Longsee Biomedical Co., Ltd Commercial: COVID-19 Ag Rapid Test Kit (Immuno-Chromatography) Device ID: 1216 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangdong Wesail Biotech Co., Ltd Commercial: COVID-19 Ag Test Kit Device ID: 1360 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Decheng Biotechnology Co., LTD Commercial: V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography) Device ID: 1324 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co., Ltd Commercial: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) Device ID: 1437 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd Commercial: COVID-19 Antigen Rapid Test Device ID: 1257 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Clongene Biotech Co., Ltd Commercial: COVID-19 Antigen Rapid Test Cassette Device ID: 1610 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Clongene Biotech Co., Ltd Commercial: Covid-19 Antigen Rapid Test Kit Device ID: 1363 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Clongene Biotech Co., Ltd Commercial: COVID-19/Influenza A+B Antigen Combo Rapid Test Device ID: 1365 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Immuno Biotech Co.,Ltd Commercial: Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive) Device ID: 1844 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Immuno Biotech Co.,Ltd Commercial: SARS-CoV-2 Antigen Rapid Test Device ID: 2317 Method: Immunoassay Target: Antigen Format: Manual 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: HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD. Commercial: COVID-19 Antigen Rapid Test Device(Colloidal Gold) Device ID: 2139 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Testsea Biotechnology Co., Ltd Commercial: COVID-19 Antigen Test Cassette Device ID: 1392 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Healgen Scientific Commercial: Coronavirus Ag Rapid Test Cassette Device ID: 1767 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hoyotek Biomedical Co.,Ltd Commercial: Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) Device ID: 1929 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hubei Jinjian Biology Co., Ltd Commercial: SARS-CoV-2 Antigen Test Kit Device ID: 1759 Method: Immunochromatography Target: Antigen Format: Automated 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: 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: 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: InTec PRODUCTS, INC. Commercial: Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen) Device ID: 2419 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd. Commercial: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit Device ID: 2107 Method: Immunochromatography Target: Antigen Format: Near POC / POC, Other Go to details
CE Marking: Yes Manufacturer: Jiangsu Diagnostics Biotechnology Co.,Ltd. Commercial: COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) Device ID: 1920 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Jiangsu Medomics medical technology Co.,Ltd. Commercial: SARS-CoV-2 antigen Test Kit (LFIA) Device ID: 2006 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Jiangsu Well Biotech Co., Ltd. Commercial: COVID-19 Ag Rapid Test Device Device ID: 2144 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Joinstar Biomedical Technology Co., Ltd Commercial: COVID-19 Rapid Antigen Test (Colloidal Gold) Device ID: 1333 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: JOYSBIO (Tianjin) Biotechnology Co., Ltd Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Device ID: 1764 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Labnovation Technologies Inc Commercial: SARS-CoV-2 Antigen Rapid Test Kit Device ID: 1266 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Lumigenex (Suzhou) Co., Ltd Commercial: PocRoc®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Device ID: 2128 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: LumiQuick Diagnostics Inc Commercial: QuickProfile COVID-19 Antigen Test Device ID: 1267 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: 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: Merlin Biomedical (Xiamen) Co., Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Device ID: 2029 Method: Immunochromatography 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

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