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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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249 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
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: Nal von minden GmbH Commercial: NADAL COVID-19 Ag Test Device ID: 1162 Method: Immunochromatography Target: Antigen Format: Manual, 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: 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) Bioingeneering 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: NG-Test SARS-CoV-2 Ag Device ID: 1646 Method: Immunochromatography Target: Antigen Format: 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
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 Plus Rapid Test Device ID: 2741 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Pantest SA Commercial: Pantest Coronavirus Ag (Nasopharyngeal Swab) Device ID: 2271 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: PerGrande BioTech Development Co. Ltd. Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) Device ID: 2116 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Pierenkemper GmbH Commercial: (SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 Device ID: 2672 Method: Immunochromatography Target: Antigen Format: Near POC / POC 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: PRIMA Lab SA Commercial: COVID-19 Antigen Rapid Test Device ID: 2685 Method: Immunochromatography 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: Qingdao Hightop Biotech Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Device ID: 1341 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC 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: 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: Rapid Pathogen Screening Inc. Commercial: LIAISON® Quick Detect Covid Ag Assay Device ID: 2290 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: RapiGEN Inc. Commercial: BIOCREDIT COVID-19 Ag Device ID: 1962 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: RapiGEN Inc. Commercial: BIOCREDIT COVID-19 Ag Test Nasal Device ID: 1963 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 Device ID: 1604 Method: Immunoassay Target: Antigen Format: 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: ROCHE Diagnostics Commercial: Elecsys® SARS-CoV-2 Antigen Device ID: 2156 Method: CLIA Target: Antigen Format: Automated, Lab-based 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: 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: 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: 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: 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 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 Nasal Device ID: 2052 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: Shenzhen CAS-Envision Medical Technology Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Detection Kit Device ID: 2152 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Dymind Biotechnology Co. Ltd. Commercial: Sars-CoV-2 antigen test kit (colloidal gold) Device ID: 2415 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Huaree Technology Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) Device ID: 2812 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Device ID: 2414 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Kingfocus Biomedical Engineering Co. Ltd. Commercial: COVID-19 Antigen Detection Kit(Quantum Dots-Based Immunofluorescence Chromatography) Device ID: 2941 Method: Immunochromatography Target: IgG, IgM, Antigen Format: Automated, Manual 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