| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: MR Healthcare | Commercial: Novel Coronavirus(COVID-19) Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MPC International S.A. | Commercial: MEDsan COVID-19 IgM/IgG Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals Germany GmbH | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: RapidScript SARS-CoV-2 Assay | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Rapid 2019-nCoV IgG/IgM Combo Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: MP Rapid 2019-nCoV IgG/IgM | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Human anti-SARS-CoV-2 IgM ELISA | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Human anti-SARS-CoV-2 IgG ELISA Kit | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: COVID-19 nucleoprotein ELISA Kit | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: ASSURE SARS-CoV-2 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Monocent, Inc | Commercial: SARS-CoV2 RT-PCR | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Monocent, Inc | Commercial: SARS-CoV2 Antigen Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Monocent, Inc | Commercial: COVID-19 IgM ELISA | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Monocent, Inc | Commercial: COVID-19 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Monocent, Inc | Commercial: COVID-19 IgG ELISA | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Monocent, Inc | Commercial: COVID-19 IgA ELISA | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: möLab GmbH | Commercial: mö-screen Corona Antigen Testr | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: möLab | Commercial: mö-screen 2019-NCOV Corona Virus Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: möLab | Commercial: COVID-19 Rapid Antigen Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mokobio Biotechnology R&D Center | Commercial: SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mobidiag | Commercial: Novodiag COVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Mobidiag | Commercial: Amplidiag COVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen GmbH | Commercial: ampliCube Coronavirus SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen GmbH | Commercial: ampliCube Coronavirus Panel | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: recomWell SARS-CoV-2 IgG | Method: Immunoassay | Target: Antibody, IgA | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MEXACARE GmbH | Commercial: MEXACARE COVID-19 Antigen Rapid Test | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Metas Biomedical Inc. | Commercial: ImmTek COVID-19 Antigen Rapid Test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Meslo | Commercial: COVID-19 qPCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MERIL DIAGNOSTICS PVT LTD. | Commercial: COVID-19 Antigen Detection Test | Method: Immunochromatography | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd | Commercial: Meril COVID-19 One-step RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc | Commercial: Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc | Commercial: Rapid COVID-19 Antigen Qualitative Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDsan GmbH | Commercial: MEDsan SARS-CoV-2 Antigen Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDsan GmbH | Commercial: MEDsan COVID-19 IgM/IgG Rapid Test Hybrid | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medisys International SA Gmate Covid-19 | Commercial: Gmate Covid-19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Medikit | Commercial: MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medigen Vaccine Biologics Corp. | Commercial: MVC SARS-CoV-2 Real-Time PCR Diagnostic Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MedicalSystem Biotechnology Co., Ltd | Commercial: COVID-19 IgM/IgG Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medical Innovation Ventures Sdn Bhd. | Commercial: GenoAmp Real-Time RT-PCR SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgG ELISA | Method: ELISA | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 NAbs (CLIA) | Method: CLIA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 IgM (CLIA) | Method: CLIA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 IgG/IgM (GICA) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 IgG (CLIA) | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 Antigen (GICA) | 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) | Method: Immunoassay | 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) | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medakit | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | 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 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | 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 | Method: | Target: Antigen | Format: Manual, 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