Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

Show advanced filters
Download as JSON, XML, CSV
305 records found
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