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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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223 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
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, Inc 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 Corporation 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: 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 (Colloidal Gold Method) Device ID: 2763 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: ScheBo Biotech AG 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: 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
CE Marking: Yes Manufacturer: Shenzhen Kisshealth Biotechnology Co., Ltd Commercial: SARS-CoV-2 Antigen Test Kit (GICA) Device ID: 1813 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Lvshiyuan Biotechnology Co., Ltd. Commercial: Green Spring SARS-CoV-2 Antigen-Rapid test-Set Device ID: 2109 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Microprofit Biotech Co., Ltd Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) Device ID: 1967 Method: Immunochromatography Target: Antigen Format: Manual 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: Shenzhen Reagent Technology Co.,Ltd. Commercial: SARS-CoV-2 antigen IVD kit SWAB Device ID: 2026 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Ultra-Diagnostics Biotec.Co.,Ltd Commercial: SARS-CoV-2 Antigen Test Kit Device ID: 2017 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Watmind Medical Co., Ltd Commercial: SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) Device ID: 1769 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Watmind Medical Co., Ltd Commercial: SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence) Device ID: 1768 Method: Immunochromatography Target: Antigen Format: Automated, Near POC / POC Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: GLINE-2019-nCoV Ag Device ID: 1347 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Siemens Healthineers Commercial: CLINITEST Rapid Covid-19 Antigen Test Device ID: 1218 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SPRING HEALTHCARE SERVICES SP Z O O Commercial: SARS-Cov-2 Antigen Rapid Test Cassette (Swab) Device ID: 1780 Method: Immunoassay Target: Antigen Format: 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: 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: Surge Medical Inc. Commercial: COVID-19 Antigen Test Kit Device ID: 1942 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Suzhou Soochow University Saier Immuno Biotech Co., Ltd. Commercial: InstantSure Covid-19 Ag CARD Device ID: 3015 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Device ID: 3093 Method: Immunoassay Target: Antigen Format: Manual, 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: Triplex International Biosciences (China) Co., LTD. Commercial: SARS-CoV-2 Antigen Rapid Test Kit Device ID: 2074 Method: Immunoassay Target: Antigen Format: Near POC / POC, Other Go to details
CE Marking: Yes Manufacturer: Triplex International Biosciences Co., Ltd Commercial: SARS-CoV-2 Antigen Rapid Test Kit Device ID: 1465 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