CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics&Instruments Co.,LTD. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva) | Device ID: 1952 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Hangzhou Zheda Dixun Biological Gene Engineering Co., Ltd. | Commercial: SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Test Cassette (Swab) | Device ID: 2942 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: Manual, 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: IEDAU INTERNATIONAL GMBH | Commercial: Covid-19 Antigen Schnelltest (Colloidales Gold) | Device ID: 2555 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid SARS-Cov2 Antigen Test | Device ID: 1791 | 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: InTec PRODUCTS, INC. | Commercial: Rapid SARS-CoV-2 Antigen Test (nasopharyngeal/nasal specimen) | Device ID: 1783 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Inzek International trading | Commercial: Biozek covid-19 Antigen Rapidtest BCOV-502 | Device ID: 1988 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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 Konsung Bio-Medical Science And Technology Co., Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1899 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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 Mole Bioscience CO., LTD. | Commercial: SARS-CoV-2 Antigen Test Cassette | Device ID: 2586 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: Jiangxi Province JinHuan Medical Instrument Co., LTD. | Commercial: DREHA Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit | Device ID: 2963 | 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: Koch Biotechnology (Beijing) Co., Ltd | Commercial: COVID-19 Antigen Rapid Test Kit | Device ID: 2038 | Method: Immunochromatography | 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: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lifecosm Biotech Limited | Commercial: COVID-19 Antigen Test Cassette | Device ID: 2866 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lifotronic Technology Co, Ltd | Commercial: Antigen Rapid Test Ag SARS-CoV-2 | Device ID: 1592 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Linkcare Health Services (Diagnos BT) | Commercial: Covid-19 Antigen Test Kit (Colloidal Gold) | Device ID: 1353 | 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 |
CE Marking: Yes | Manufacturer: möLab | Commercial: mö-screen Corona Antigen Test | Device ID: 1190 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Mologic Ltd | Commercial: COVIOS Ag COVID-19 Antigen Rapid Diagnostic Test | Device ID: 2640 | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 1481 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Multi-G bvba | Commercial: Covid19Check-NAS | Device ID: 2260 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Nanjing Liming Bio-Products Co., Ltd. | Commercial: StrongStep® SARS-CoV-2 Antigen Rapid Test | Device ID: 2301 | 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: Nanjing Synthgene Medical Technology Co., Ltd. | Commercial: SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) | Device ID: 2164 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: NanoRepro AG | Commercial: NanoRepro SARS-CoV-2 Antigen Rapid Test | Device ID: 2200 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Nantong Egens Biotechnology Co.,Ltd | Commercial: COVID-19 Antigen Rapid Test Kit | Device ID: 1573 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: NDFOS Co., Ltd. | Commercial: ND COVID-19 Ag Test | Device ID: 2678 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd. | Commercial: COVID 19 Antigen Test Kit (Colloidal Gold Method) | Device ID: 2608 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: NESAPOR EUROPA SL | Commercial: MARESKIT | Device ID: 2241 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co., Ltd. | Commercial: COVID-19 Antigen Detection Kit | Device ID: 1501 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual, 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: Novatech | Commercial: SARS CoV-2 Antigen Rapid Test | Device ID: 1762 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Oncosem Onkolojik Sistemler San. ve Tic. A.S. | Commercial: CAT | Device ID: 1199 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Ortho Clinical Diagnostics | Commercial: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen | Device ID: 1200 | Method: CLIA | Target: Antigen | Format: Automated, Lab-based | 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