| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Medigen Vaccine Biologics Corp. | Commercial: MVC SARS-CoV-2 Convective PCR Diagnostic Device/Kit | Device ID: 581 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Medigen Vaccine Biologics Corp. | Commercial: MVC SARS-CoV-2 Real-Time PCR Diagnostic Kit | Device ID: 582 | 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) | Device ID: 796 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medisys International SA Gmate Covid-19 | Commercial: Gmate Covid-19 | Device ID: 862 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MedMira Laboratories Inc. | Commercial: REVEALCOVID-19(TM) Total Antibody Test | Device ID: 2383 | Method: Immunoassay | Target: Antibody, IgA, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDsan GmbH | Commercial: MEDsan COVID-19 IgM/IgG Rapid Test Hybrid | Device ID: 1068 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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: MEDsan GmbH | Commercial: MEDsan® SARS-CoV-2 Ag Duo | Device ID: 3111 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDsan® GmbH | Commercial: MEDsan® SARS-CoV-2 Ag Duo | Device ID: 3954 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Medsource Ozone Biomedicals | Commercial: COVID 19 IgG IgM Rapid Test | Device ID: 583 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: MedStar Medical Co. Ltd. | Commercial: One-step Direct Realtime PCR Test Kit of 2019-nCoV Coronavirus | Device ID: 278 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Medusa19 Life Sciences | Commercial: MeduFlow | Device ID: 2905 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc. | Commercial: Rapid COVID-19 Antigen Qualitative Test Kit | Device ID: 1182 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc. | Commercial: Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody) | Device ID: 1063 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: COVID-19 Antigen Detection Test | Device ID: 1894 | Method: Immunochromatography | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: COVIFIND COVID-19 Antigen Self Test | Device ID: 2923 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: COVIFIND COVID-19 Antigen Test | Device ID: 2924 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: Meril COVID-19 One-step RT-PCR Kit | Device ID: 792 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: MERISCREEN COVID-19 Antigen Detection Test | Device ID: 2582 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Merlin Biomedical (Xiamen) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2596 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Merlin Biomedical (Xiamen) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2029 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Merlin Biomedical (Xiamen) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette (saliva) | Device ID: 2030 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Mesa Biotech | Commercial: Accula SARS-CoV-2 test | Device ID: 736 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Meslo | Commercial: COVID-19 qPCR kit | Device ID: 897 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Metas Biomedical Inc. | Commercial: ImmTek COVID-19 Antigen Rapid Test | Device ID: 1928 | 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: No | Manufacturer: MGI Tech Co. Ltd. | Commercial: Fast SARS-CoV-2 NAT with CRISPR assay by digital microfluidics automation | Device ID: 483 | Method: CRISPR | Target: Nucleic acid | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Michael Bubolz GmbH | Commercial: Vibamat | Device ID: 4148 | Method: Immunoassay | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Detection Kit, nCoV-OS | Device ID: 2795 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Detection Kit, nCoV-QS | Device ID: 2794 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-OM | Device ID: 2797 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-QM | Device ID: 2796 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-QM-N | Device ID: 2799 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-VM | Device ID: 2798 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: COVID-19 Biokit IgG/IgM | Device ID: 2793 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: MiCo BioMed Co., Ltd. | Device ID: 2827 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Veri-Q COVID-19 & Flu A/B Multiplex Detection Kit | Device ID: 2801 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: VERI-Q COVID-19 Ag Rapid Test | Device ID: 2792 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Veri-Q COVID-19 IgG ELISA Kit | Device ID: 2789 | Method: ELISA | Target: IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Veri-Q COVID-19 SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit | Device ID: 2790 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: VERI-Q PCR 316 COVID-19 detection system | Device ID: 280 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Veri-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit | Device ID: 2791 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Veri-Q Viral DNA/RNA Prep Kit | Device ID: 2805 | Method: Other | Target: Nucleic acid | Format: Semi-automated | Go to details |
| CE Marking: No | Manufacturer: MicroGenDx | Commercial: COVID-19 Key | Device ID: 737 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Microgenics Corporation | Commercial: ASAPath COVID-19 Antigen Rapid Test | Device ID: 2179 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MICROTRACE DIAGNOSTICI | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2123 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Microtrace Diagnostici SRL | Commercial: 2019 NCOV IGG/IGM TEST | Device ID: 1020 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: ampliCube Coronavirus Panel | Device ID: 282 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: ampliCube Coronavirus SARS-CoV-2 | Device ID: 281 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: recomWell SARS-CoV-2 IgG | Device ID: 1629 | Method: Immunoassay | Target: Antibody, IgA, IgG | Format: Lab-based | 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