CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
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: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Rapid Antigen Test | Device ID: 1604 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Sansure Biotech Inc. | Commercial: SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) | Device ID: 2097 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Rapid Antigen Test 2.0 | Device ID: 25546 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SARS-CoV-2 Rapid Antigen Test Cassette | Device ID: 2297 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Rapid Antigen Test Nasal | Device ID: 2228 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 1178 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay) | Device ID: 1228 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test | Device ID: 2754 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2( COVID-19)Antigen Rapid Detection Kit (Lateral Flow Method) | Device ID: 2491 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: ScheBo Biotech | Commercial: ScheBo SARS CoV-2 Quick Antigen | Device ID: 1201 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ScheBo Biotech | Commercial: ScheBo SARS CoV-2 Quick ANTIGEN (Colloidal Gold Method) | Device ID: 2763 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) | Device ID: 1849 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - Nasal swab | Device ID: 3107 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Sugentech Inc. | Commercial: SGTi-flex COVID-19 Ag | Device ID: 1114 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: Sofia SARS Antigen FIA | Device ID: 1097 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ZET medikal tekstil dis tic Ltd. sti | Commercial: SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT | Device ID: 2226 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD F COVID-19 Ag FIA | Device ID: 344 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD F COVID-19 Ag FIA | Device ID: 24759 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD F COVID/Flu Ag Combo FIA | Device ID: 24757 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD i-Q COVID/Flu Ag Combo Test | Device ID: 24756 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD Q COVID-19 Ag Test | Device ID: 345 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD Q COVID-19 Ag Test 2.0 | Device ID: 24758 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD Q COVID-19 Ag Test Nasal | Device ID: 2052 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Nanjing Liming BioProducts 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: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: TEST IT Covid-19 Ag Test | Device ID: 1689 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid Covid-19 Antigen (tampon nazofaringian) | Device ID: 1225 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 Antigen Test | Device ID: 2130 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Wuhan Life Origin Biotech Joint Stock Co. Ltd. | Commercial: The SARS-CoV-2 Antigen Assay Kit (Immunochromatography) | Device ID: 1773 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: TODA CORONADIAG Ag | Device ID: 1466 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: TOYO Covid-19 Ag Test | Device ID: 1722 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SD Biosensor Healthcare Private Limited | Commercial: Ultra COVID-19 Ag | Device ID: 3026 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold) | Device ID: 1319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold) | Device ID: 1357 | Method: Immunoassay | Target: Antigen | Format: 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: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: Verino Pro SARS CoV 2 Ag Rapid Test | Device ID: 2100 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Genobio Pharmaceutical Co. Ltd. | Commercial: Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Device ID: 2642 | 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 |
CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold) | Device ID: 1485 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Willi Fox GmbH | Commercial: Willi Fox COVID-19 Antigen rapid Test | Device ID: 1276 | Method: Immunoassay | Target: Antigen | Format: Manual, 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: 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