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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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291 records found
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