| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: LumiraDx SARS-CoV-2 Ag Ultra | Device ID: 3836 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: LumiraDx SARS-COV-2 Antigen Pool Test | Device ID: 2342 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: LumiraDx SARS-CoV-2 RNA STAR Complete | Device ID: 2645 | Method: RT-PCR | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: SARS-CoV-2 & Flu A/B RNA STAR Complete | Device ID: 3840 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: SARS-CoV-2 Antibody Test | Device ID: 1147 | Method: Immunoassay | Target: Antibody, IgA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: SARS-CoV-2 Antigen Test | Device ID: 1146 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Luxus Lebenswelt GMBH (Beijing NaGene Diagnosis Reagent Co. Ltd.) | Commercial: COVID-19 mouth and throat Swab | Device ID: 961 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: M.I.Tech Co. Ltd. | Commercial: RAPICHECK COVID-19 Ag | Device ID: 2928 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mabsky Bio-Tech Co. Ltd. | Commercial: COVID-19 virus (2019-nCoV) Dual-Detection Kit | Device ID: 269 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mabsky Bio-Tech Co. Ltd. | Commercial: COVID-19 virus (2019-nCOV) Triple-Detection Kit (Real-Time PCR Method) | Device ID: 271 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mabsky Bio-Tech Co. Ltd. | Commercial: Influenza A virus, Influenza B virus & COVID-19 virus (2019-nCoV) Triple-Detection Kit | Device ID: 270 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: Maccura SARS-CoV-2 IgG | Device ID: 1034 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: Maccura SARS-CoV-2 IgM | Device ID: 1033 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Fluorescent PCR | Device ID: 272 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Fluorescent PCR Kit | Device ID: 1916 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 IgG (CLIA) | Device ID: 989 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 IgM (CLIA) | Device ID: 988 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Kit (CLIA) | Device ID: 1953 | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method | Device ID: 1917 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method | Device ID: 1918 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Macrogen | Commercial: AxenTM COVID-19 Ag RAPID | Device ID: 2125 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Macrogen | Commercial: AxenTM COVID-19 IgM/IgG RAPID | Device ID: 2126 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Mammoth Biosciences | Commercial: SARS-CoV-2 DETECTR | Device ID: 273 | Method: CRISPR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Manufactured by Eon Biotechnology Limited | Commercial: EONBT COVID-19 ANTIGEN-SALIVA | Device ID: 2161 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: möLab | Commercial: mö-screen 2019-NCOV Corona Virus Test | Device ID: 997 | Method: Immunoassay | Target: Antibody | 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: MD-Bio Inc. | Commercial: MD-Bio BCC19 Test Kit | Device ID: 2952 | Method: LAMP | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MED TRUST Handelsges.m.b.H. | Commercial: Wellion SARS-CoV-2 PLUS ANTIGEN Rapid Test | Device ID: 2162 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medakit Ltd. | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | Device ID: 1785 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medakit Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Device ID: 1784 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: Flu A/Flu B/SARS-CoV-2 Antigen (GICA) | Device ID: 1713 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen (GICA) | Device ID: 1711 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 IgG (CLIA) | Device ID: 1709 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 IgG/IgM (GICA) | Device ID: 1712 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 IgM (CLIA) | Device ID: 1710 | Method: CLIA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 NAbs (CLIA) | Device ID: 1708 | Method: CLIA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgA ELISA | Device ID: 1626 | Method: ELISA | Target: Antibody, IgA | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgG ELISA | Device ID: 1625 | Method: ELISA | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgM ELISA | Device ID: 1627 | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Medical & Biological Laboratories Co. Ltd. | Commercial: FLUOROSEARCH Novel Coronavirus (SARS-CoV-2) Detection Kit | Device ID: 274 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Medical Innovation Ventures Sdn Bhd. | Commercial: GenoAmp Real-Time RT-PCR SARS-CoV-2 | Device ID: 275 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Device ID: 735 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Device ID: 2050 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: Coronavirus Disease 2019 Real Time PCR Kit | Device ID: 2051 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: COVID-19 Ag Rapid Test Cassette | Device ID: 2049 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: COVID-19 IgM/IgG Rapid Test Cassette | Device ID: 276 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDICE Arzneimittel Pütter GmbH & Co. KG | Commercial: Medicovid-AG SARS-CoV-2 Antigen Schnelltest-Nase | Device ID: 2526 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDICE Arzneimittel Pütter GmbH & Co. KG | Commercial: Medicovid-AG SARS-CoV-2 Antigen Selbsttest-Nase | Device ID: 2318 | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Mediclone Biotech Pvt Ltd. | Commercial: @sight COVID-19 IgG/IgM Rapid Test Kit | Device ID: 277 | Method: Immunoassay | Target: Antibody | Format: 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 |
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