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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: Vitrosens Biotechnology Co. Ltd. Commercial: ENMED SARS-CoV-2 Rapid Antigen Test Kit Device ID: 4083 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Fujirebio Commercial: ESPLINE SARS-CoV-2 Device ID: 2147 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: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Device ID: 1457 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: ACON Laboratories Inc. Commercial: Flowflex SARS-CoV-2 Antigen rapid test Device ID: 1468 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Nasopharyngeal/Saliva) Device ID: 4057 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) Device ID: 1865 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Slim Device ID: 4053 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. Commercial: Fosun Covid-19 Ag CARD Device ID: 2724 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: NanoEntek Commercial: FREND COVID-19 Ag Device ID: 1420 Method: Immunoassay Target: Antigen Format: Automated Go to details
CE Marking: Yes Manufacturer: GA Generic Assays GmbH Commercial: GA CoV-2 Antigen Rapid Test Device ID: 1855 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: General Biologicals Corporation Commercial: GB COVID-19 Ag POCT Device ID: 4081 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenBody Inc. Commercial: GenBody COVID-19 Ag Device ID: 1244 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GC Medical Science Corp. Commercial: GENEDIA W COVID-19 Ag Device ID: 1144 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GC Medical Science Corp. Commercial: GENEDIA W COVID-19 Ag (643K) Device ID: 3190 Method: Immunochromatography 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 Plus Rapid Test Device ID: 2741 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenSure Biotech Inc. Commercial: GenSure COVID-19 Antigen Rapid Kit Device ID: 1253 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: GenSure Biotech Inc. Commercial: GenSure COVID-19 Antigen Rapid Test Kit Device ID: 2853 Method: Immunoassay Target: Antigen Format: Manual 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: 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: Hangzhou AllTest Biotech Co. Ltd. Commercial: GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) Device ID: 2325 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Humasis Co. Ltd. Commercial: Humasis COVID-19 Ag Test Device ID: 1263 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. Commercial: INFO Covid-19 Ag Test Device ID: 2584 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Innova Medical Group Inc. Commercial: Innova SARS CoV-2 Antigen Rapid Qualitative Test Device ID: 1801 Method: Immunoassay Target: Antigen Format: Near POC / POC 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: SG Medical Inc. Commercial: InstaView COVID-19 Antigen Device ID: 2935 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Abionic SA Commercial: IVD CAPSULE COVID-19-NP Device ID: 2975 Method: Immunoassay Target: Antigen Format: Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd. Commercial: KaiBiLi COVID-19 Antigen Pro Device ID: 2885 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: AVALUN SAS Commercial: Ksmart® SARS-COV2 Antigen Rapid Test Device ID: 1800 Method: Immunochromatography Target: Antigen Format: Semi-automated 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: DiaSorin S.p.A Commercial: LIAISON® SARS-CoV-2 Ag Device ID: 1960 Method: CLIA Target: Antigen Format: Automated, Lab-based Go to details
CE Marking: Yes Manufacturer: Lomina Superbio a.s. Commercial: Lomina SARS-CoV-2 Antigen LTX test Device ID: 2560 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Fujirebio Inc. Commercial: Lumipulse G SARS-CoV-2 Ag Device ID: 2124 Method: Immunoassay Target: Antigen Format: Automated, Fully automated (robot), Lab-based Go to details
CE Marking: Yes Manufacturer: LumiraDx UK Ltd. Commercial: LumiraDx SARS-CoV-2 Ag Test Device ID: 1268 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Laihe Biotech Co. Ltd. Commercial: LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) Device ID: 1215 Method: Immunoassay Target: Antigen Format: Near POC / POC 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: ArcDia International Ltd. Commercial: mariPOC Quick Flu+ Device ID: 2079 Method: Immunoassay Target: Antigen Format: Automated, Near POC / POC Go to details
CE Marking: Yes Manufacturer: ArcDia International Ltd. Commercial: mariPOC Respi+ Device ID: 2078 Method: Immunoassay Target: Antigen Format: Automated, Near POC / POC Go to details
CE Marking: Yes Manufacturer: ArcDia International Ltd. Commercial: mariPOC SARS-CoV-2 Device ID: 768 Method: Immunoassay Target: Antigen Format: Automated, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Medifood Hungary Innovation Kft. Commercial: MediDia COVID-19 Ag Device ID: 2973 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEDsan GmbH Commercial: MEDsan SARS-CoV-2 Antigen Rapid Test Device ID: 1180 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Jiangxi Province JinHuan Medical Instrument Co. Ltd. Commercial: MEDSYS Novel Coronavirus (SARS-CoV-2) Antigen Rapid Detection Kit Device ID: 3004 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: MEXACARE GmbH Commercial: MEXACARE COVID-19 Antigen Rapid Test Device ID: 1775 Method: Chromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: möLab Commercial: mö-screen Corona Antigen Test Device ID: 1190 Method: Immunochromatography Target: Antigen Format: Manual, 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: BIOTEKE CORPORATION (WUXI) Co. Ltd. Commercial: Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay) Device ID: 5827 Method: Immunochromatography Target: Antigen Format: Near POC / POC 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: 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: NDFOS Co. Ltd. Commercial: ND COVID-19 Ag Test Device ID: 2678 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