CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Mobidiag | Commercial: Amplidiag COVID-19 | Device ID: 935 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Mobidiag | Commercial: Novodiag COVID-19 | Device ID: 936 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Mobidiag | Commercial: Novodiag COVID-19 + InfA/B | Device ID: 283 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Module Innovations Private Ltd. | Commercial: nCoVSENSe: IgM/ IgG test for spike and N-protein of SARS-CoV 2 (manual) | Device ID: 284 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Mokobio Biotechnology R&D Center | Commercial: SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay | Device ID: 285 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Molbio Diagnostics Private Limited | Commercial: Truenat® COVID-19 | Device ID: 2913 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Molbio Diagnostics Private Limited | Commercial: Truenat® SARS CoV-2 | Device ID: 286 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Molgentix S.L. | Commercial: CoviNplex™ One Step RT-PCR Kit For qualitative detection of SARS-CoV-2 assay | Device ID: 2176 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Mologic Ltd. | Commercial: COVIOS Ag COVID-19 Antigen Rapid Diagnostic Test | Device ID: 2640 | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Mologic Ltd. | Commercial: Mologic COVID-19 Rapid Test | Device ID: 287 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MONLAB SL | Commercial: SARS-CoV-2 MONLABTEST | Device ID: 1961 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Monocent Inc. | Commercial: COVID-19 IgA ELISA | Device ID: 1329 | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Monocent Inc. | Commercial: COVID-19 IgG ELISA | Device ID: 1327 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Monocent Inc. | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 1321 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Monocent Inc. | Commercial: COVID-19 IgM ELISA | Device ID: 1328 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Monocent Inc. | Commercial: SARS-CoV2 Antigen Rapid Test | Device ID: 1320 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Monocent Inc. | Commercial: SARS-CoV2 RT-PCR | Device ID: 1330 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: mosaiques diagnostics GmbH | Commercial: DiaPat-CoV-50 | Device ID: 2407 | Method: Other | Target: | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Mount Sinai Labs | Commercial: COVID-19 ELISA IgG Antibody Test | Device ID: 738 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: ASSURE SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 937 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: COVID-19 nucleoprotein ELISA Kit | Device ID: 1123 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Human anti-SARS-CoV-2 IgG ELISA Kit | Device ID: 1125 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Human anti-SARS-CoV-2 IgM ELISA | Device ID: 1124 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: MP Rapid 2019-nCoV IgG/IgM | Device ID: 584 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Rapid 2019-nCoV IgG/IgM Combo Test | Device ID: 1126 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 1481 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: RapidScript SARS-CoV-2 Assay | Device ID: 1127 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MPC International S.A. | Commercial: MEDsan COVID-19 IgM/IgG Rapid Test | Device ID: 1051 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MR Healthcare | Commercial: Novel Coronavirus(COVID-19) Test | Device ID: 1021 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MSP bodmann GmbH | Commercial: MSP SARS-CoV-2 Antigen Schnelltest | Device ID: 2532 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Multi-G bvba | Commercial: Covid19Check-GEN | Device ID: 2258 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Multi-G bvba | Commercial: Covid19Check-MG | Device ID: 2262 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Multi-G bvba | Commercial: Covid19Check-NAS | Device ID: 2260 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Multi-G bvba | Commercial: Covid19Check-SAL | Device ID: 2261 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Multibrands Trading(Suzhou) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Qualitative Test | Device ID: 2534 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19 qPCR Allplex | Device ID: 2027 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTest COVID-19 qPCR ALLPLEX Kit | Device ID: 1692 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTest COVID-19 qPCR MULTIPLEX | Device ID: 1315 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19 qPCR Rapid Kit | Device ID: 2859 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19 qPCR SuperRapid Kit | Device ID: 3156 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19/FLU qPCR DIAGNOSTIC KIT | Device ID: 1332 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: vDetect COVID-19 RT-qPCR diagnostic kit | Device ID: 1077 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: Vivid COVID-19 LAMP Direct-G | Device ID: 2960 | Method: LAMP | Target: | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: COMPACT MINI/DX/XLDX- Nucleic Acid Amplification (PCR) Analyzer | Device ID: 2359 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: COMPACT X/COMPACT XL- Nucleic Acid Sample Extraction and Preparation Instrument | Device ID: 2344 | Method: RT-PCR | Target: | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test | Device ID: 2343 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Magnetic Bead Based) | Device ID: 2355 | Method: | Target: | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Magnetic Bead Based-Compatible with COMPACTX/XL) | Device ID: 2356 | Method: RT-PCR | Target: Nucleic acid | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Spin Column Based) | Device ID: 2347 | Method: RT-PCR | Target: | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: MyBox Flurescence Immunoassay Analyzer | Device ID: 2423 | Method: Immunoassay | Target: Antigen | Format: Automated | 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