| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: INGEZIM COVID 19 DR | Device ID: 1683 | Method: ELISA | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: NovaLisa SARS-CoV-2 IgG assay | Device ID: 725 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: VIROTECH SARS-CoV-2 IgG | Device ID: 880 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins GeneScan Technologies GmbH | Commercial: GSD NovaPrime IVD RNA Extraction AE2 | Device ID: 2666 | Method: Other | Target: | Format: Automated, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins GeneScan Technologies GmbH | Commercial: IFU NovaPrime IVD RNA Extraction AE1 RTU | Device ID: 2665 | Method: Other | Target: | Format: Automated, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins GeneScan Technologies GmbH | Commercial: NovaPrime IVD RNA Extraction AE1 | Device ID: 2664 | Method: Other | Target: | Format: Automated, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: EUROFINS INGENASA | Commercial: INGEZIM COVID 19 SPIKE CROM | Device ID: 2458 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EUROFINS INGENASA | Commercial: INGEZIM COVID RBD-DR | Device ID: 2552 | Method: ELISA | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 ELISA (IgA) | Device ID: 160 | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 ELISA (IgG) | Device ID: 883 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 QuantiVac ELISA (IgG) | Device ID: 2743 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2-NCP ELISA (IgG) | Device ID: 849 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: EURORealTime SARS-CoV-2 | Device ID: 159 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: SARS-CoV-2 Antigen ELISA | Device ID: 2289 | Method: ELISA | Target: Antigen | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: SARS-CoV-2 NeutraLISA | Device ID: 2751 | Method: ELISA | Target: Antibody, IgA, IgG, IgM | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Exact Sciences | Commercial: SARS-CoV-2 Test | Device ID: 719 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Excalibur Healthcare Services Limited | Commercial: RAPID SARS-COV-2 ANTIGEN SCREENING TEST CARD | Device ID: 2876 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EXON BÄ°YOTEKNOLOJÄ° | Commercial: EXON SARS CoV-2 Rapid Antigen Test (Colloidal Gold) | Device ID: 2953 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EXON BIYOMEDIKAL | Commercial: EXON SARS-CoV-2 Real Time PCR Tanı Kiti | Device ID: 1738 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: EXPERTEAM SRL | Commercial: EXPERT COVID-19 KIT 1-RQ | Device ID: 2064 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: EXPERTEAM SRL | Commercial: EXPERT COVID-19 VRT KIT 2-RQ | Device ID: 2065 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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 Coronavirus (2019-nCoV) Antigentest | Device ID: 2172 | Method: Immunoassay | Target: Antigen | 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: fago medikal san. tic. Ltd. ÅŸti. | Commercial: FAMEX SARS-CoV-2 RAPID ANTIBODY TEST | Device ID: 2175 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: fago medikal san. tic. Ltd. ÅŸti. | Commercial: FAMEX SARS-CoV-2 SALIVA ANTIGEN TEST KIT | Device ID: 2174 | 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: Fast Track Diagnostics | Commercial: FTD-114 SARS-CoV-2 (manual & lab-based NAT) | Device ID: 163 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: FemtoDx | Commercial: COVID-19 Antibody Test | Device ID: 164 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: FemtoDx | Commercial: COVID-19 Rapid Home Nucleic Acid Test | Device ID: 165 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 2597 | Method: Immunochromatography | Target: Antigen | Format: 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: Fjord Diagnostics SDN | Commercial: BHD SEDIPREP COVID-19 | Device ID: 924 | Method: Other | Target: Other | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Fjord Diagnostics SDN | Commercial: Viral Transport Medium | Device ID: 551 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: FluroTest LLC | Commercial: CompleTest | Device ID: 553 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Fluxergy Inc. | Commercial: Fluxergy Test Kit COVID-19 | Device ID: 167 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 1871 | Method: Other | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold) | Device ID: 1872 | Method: Other | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit(Multiplex PCR Fluorescent Probe Method) | Device ID: 1869 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co. Ltd. | Commercial: SARS-CoV-2 Variant Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) | Device ID: 2071 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | 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 |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Covid-19 Antigen CARD Kit | Device ID: 4055 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun 2019-nCoV IgM/IgG rapid | Device ID: 2716 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun 2019-nCoV qPCR | Device ID: 2713 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun 2019-nCoV rapid | Device ID: 2715 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Anti-SARS-CoV-2 S-RBD | Device ID: 2725 | Method: | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Covid-19 Ab CARD | Device ID: 2718 | Method: | Target: | Format: | 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: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun Covid-19 Ag Test | Device ID: 2728 | Method: | Target: Antigen | Format: | 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