CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
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: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit - Nasal Swab (for Self-Test use) | Device ID: 2303 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: COVID-19 and Influenza A+B Rapid Antigen Combo Test | Device ID: 2845 | Method: Immunoassay | Target: Antigen | Format: Manual, 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: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 Ag Dipstick | Device ID: 1593 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 Ag Dipstick Self Test | Device ID: 3100 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 Ag Plus Rapid Test | Device ID: 2741 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 Ag Self Test | Device ID: 2806 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Panion & BF Biotech Inc. | Commercial: Vstrip Covid-19 Antigen Rapid Test | Device ID: 1379 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag | Device ID: 1270 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Philosys | Commercial: Gmate® COVID-19 Ag | Device ID: 1611 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Philosys | Commercial: Gmate® COVID-19 Ag Saliva | Device ID: 1854 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Philosys | Commercial: SoluM COVID 19-Ag | Device ID: 2830 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Philosys | Commercial: SoluM COVID-19 Ag Saliva | Device ID: 2829 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Precision Biosensor | Commercial: Exdia COVID-19 Ag | Device ID: 1271 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV Antigen Device | Device ID: 1202 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Rapid Test Ag 2019-nCov | Device ID: 1495 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Promoitalia Group SpA | Commercial: DROP-TECH | Device ID: 1733 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: Sofia Flu + SARS Antigen FIA | Device ID: 2682 | Method: Immunoassay | Target: Antigen | Format: Automated, Lab-based, Near POC / POC, Other | 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: RDSM nv | Commercial: COVID-19 Antigen test | Device ID: 1238 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Reach Diagnostic (Wuhan) Biotech Co. Ltd. | Commercial: SARS-COV-2 Ag Rapid Test | Device ID: 2954 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Redcell Biyoteknoloji | Commercial: COVID-19 Antigen Test | Device ID: 1715 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Response Biomedical Corp. | Commercial: RAMP COVID-19 Antigen Test | Device ID: 2095 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: Safecare Biotech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Swab) | Device ID: 1489 | 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: Salofa Oy | Commercial: Salocor SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2129 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Salocor SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2240 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Sienna COVID-19 Antigen Rapid Test Cassette | Device ID: 2127 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SCREEN ITALIA S.r.l. | Commercial: SCREEN TEST COVID-19 AG - COVID-19 ANTIGEN RAPID TEST | Device ID: 1681 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SCREEN ITALIA S.r.l. | Commercial: Screentest Covid-19+FLU A/B | Device ID: 1590 | 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: 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: Sensing Self Pte. Ltd. | Commercial: S1 Covid-19 Rapid Antigen Test Kit | Device ID: 1493 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Sensitest | Commercial: Sensitest Joysbio Antigen Rapid Test for Covid-19 | Device ID: 1272 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Sensiva Health LLC | Commercial: Sensiva Health React Rapid Antigen Test (Lateral Flow Method) | Device ID: 2611 | Method: Immunoassay | Target: Antigen | Format: Manual, 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: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (IFA) | Device ID: 1317 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SGA Medikal ( SGA Muhendislik Dans Egt Ic ve Dis Tic A.S.) | Commercial: ViruScan SARS-CoV-2 Rapid Antigen Test | Device ID: 5732 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: SHANDONG KANGHUA BIOTECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Immunochromatography) | Device ID: 1366 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 Ag Rapid Test (Colloidal Gold) | Device ID: 2313 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 (SARs-Cov-2)Antigen Rapid Test Kit (Nasal Swab) | Device ID: 2512 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19(SARS-CoV-2)Antigen Rapid Test Kit (Nasal Swab) - self-test | Device ID: 3080 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen AIVD Biotech Inc. | Commercial: COVID-19/ FluA/ FluB Antigen Combo Rapid Test Kit (Colloidal Gold Method) | Device ID: 3087 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Bioeasy Biotechnology Co. Ltd. | Commercial: Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) | Device ID: 365 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Bioeasy Biotechnology Co. Ltd. | Commercial: Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test | Device ID: 689 | Method: Immunoassay | 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