CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 Ag Rapid Test | Device ID: 1581 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 IgG/IgM Rapid Test | Device ID: 902 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Dablood pharmaceutical | Commercial: DABLOOD COVID-19 IgM/IgG Rapid Antibody Test | Device ID: 1634 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid Combo Covid-19/Influenza A+B Antigen | Device ID: 1305 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid Combo Covid-19/Influenza A+B Antigen (tampon nazofaringian)) | Device ID: 1226 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid Covid-19 Antigen (tampon nazal) | Device ID: 2986 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: DDS DIAGNOSTIC SRL | Commercial: Test Rapid IgG/IgM 2019-nCoV | Device ID: 1073 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: One check 2019-nCoV IgG/IgM | Device ID: 1007 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: OneCheck Covid-19 IgG Spike RBD | Device ID: 2638 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: SARS-CoV-2 Antigen | Device ID: 2457 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Diacarta Inc. | Commercial: QuantiVirus SARS-CoV-2 Antigen Rapid Test | Device ID: 3001 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. | Commercial: nCOV IgG/IgM Rapid Test | Device ID: 1078 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. | Commercial: OneStep COVID-19 Antigen RapiCard InstaTest | Device ID: 1195 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: Diaquick Covid-19 IgG/IgM | Device ID: 1055 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: DIAQUICK COVID-19 IgG/IgM Cassette Rapid Test | Device ID: 986 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) | Device ID: 2096 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2203 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: DIAsource ImmunoAssays | Commercial: COVID-19 Antigen Rapid Test | Device ID: 1792 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DNA Diagnostic | Commercial: COVID-19 Antigen Detection Kit | Device ID: 2242 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DNA Diagnostic | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2756 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dräger Safety AG & Co. KGaA | Commercial: Dräger Antigen Test SARS-CoV-2 | Device ID: 2273 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dräger Safety AG & Co. KGaA | Commercial: Dräger COVID-19 Home Test | Device ID: 2647 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DS Bio and Nano Technology Product Tracking Verification Corp. | Commercial: DS AntijenX | Device ID: 2551 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod® SARS-CoV-2 IgG Test Kit | Device ID: 1719 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod®616 IgG Test Kit | Device ID: 1720 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co. Ltd. | Commercial: 2019 nCOV IgG/IgM Rapid Test | Device ID: 152 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology(Tianjin) Co. Ltd. | Commercial: Dynamiker SARS-CoV-2 Ag Rapid Test | Device ID: 3995 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: CORONA-Ag | Device ID: 1662 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: CovidAg | Device ID: 1663 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: DyonCovid19 - SARS-CoV-2 IgM/IgG Antibody Rapid Test Device. | Device ID: 991 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: DyonCovidAg | Device ID: 1651 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: FluCov2 | Device ID: 1664 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: SieloCovidAg | Device ID: 2007 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: 2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) | Device ID: 156 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: ActivXpress+ COVID-19 Antigen Complete Testing Kit | Device ID: 1243 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined | Device ID: 662 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: EMBIO Diagnostics Ltd. | Commercial: CovBELD | Device ID: 1313 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: EON Biotechnology Limited | Commercial: EONBT COVID-19 Antigen | Device ID: 2032 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Eternal Material Co.,Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 3443 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Eternal Material Co.,Ltd. | Commercial: COVID-19 Antigen Rapid Test For Self Test | Device ID: 3453 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Eternal Materials Co. Ltd. | Commercial: COVIDual COVID-19 IgM/IgG Rapid Test | Device ID: 1066 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Eurobio Scientific | Commercial: EBS SARS-CoV-2 Ag Rapid Test | Device ID: 1739 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Eurofins | Commercial: INGEZIM Covid 19 CROM | Device ID: 1682 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: FAGO MEDÄ°KAL SANAYÄ° TÄ°CARET Ltd. ÅžTÄ°. | Commercial: FAMEX Coronavirus (2019-nCoV) Antigentest | Device ID: 2053 | Method: Immunochromatography | Target: Nucleic acid | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: fago medikal san. tic. Ltd. ÅŸti. | Commercial: FAMEX SARS-CoV-2 AG RAPID NASOPHARTNGEAL TEST KIT | Device ID: 2173 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: fameditec GmbH | Commercial: CORA CHECK-19 | Device ID: 1744 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: fameditec GmbH | Commercial: CORA-CHECK-19-comfort | Device ID: 1781 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Detection Kit | Device ID: 2598 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Formosa Biomedical Technology Corp. | Commercial: Formosa One Sure SARS-CoV-2 Ag Rapid Test Kit | Device ID: 1208 | 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