| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: 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: 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: 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: 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: 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: 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: No | Manufacturer: MicroGenDx | Commercial: COVID-19 Key | Device ID: 737 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: 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: 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: 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: No | Manufacturer: Nanjing BioPoint Diagnostics | Commercial: BioPoint SARS-CoV-2 dIgA/total antibody rapid test | Device ID: 290 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nanjing Liming BioProducts Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 681 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nanjing Liming BioProducts Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit | Device ID: 680 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: NanoBio Lab A*STAR Research Entities | Commercial: Isothermal Exponential Amplification for COVID-19 Detection | Device ID: 292 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: NanoEntek | Commercial: FREND COVID-19 total Ab | Device ID: 1418 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: NanoResearch | Commercial: NanoMedicina SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 683 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nationwide Children's Hospital | Commercial: SARS-CoV-2 Assay | Device ID: 739 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Naturitious LLC | Commercial: Viralert COVID-19 IgG/IgM Antibody Rapid Test Kit | Device ID: 484 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Navid | Commercial: COVID-19 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method) | Device ID: 326 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: NEMHESIS LAB. SÄ°S. MED. PLAS. ENJEK. Ä°ML. Ä°TH. Ä°HR. SAN. TÄ°C. Ltd. ÅžTÄ°. | Commercial: NEMI COVID-19 RAPID ANTIGEN TEST KIT | Device ID: 3155 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Ningbo Beautiful Life Medical Biotechnology Development Co. Ltd. | Commercial: Saliva SARS-Cov-2(2019-nCoV) Antigen Combined Test Kit (Nanocarbon Assay) | Device ID: 2250 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Ningbo Health Gene Technologies Co. Ltd. | Commercial: SARS-CoV-2 Virus Detection Diagnostic Kit (RT- qPCR Method) | Device ID: 296 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech Inc. | Commercial: pGOLD COVID-19 IgG/IgM/IgA Microarray Test | Device ID: 793 | Method: Other | Target: Antibody, IgA, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech Inc. | Commercial: Rapid COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit | Device ID: 297 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Norgen Biotek Corp. | Commercial: 2019-nCoV TaqMan RT-PCR Kit (Catalog# TM67100) | Device ID: 298 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: NorthShore University HealthSystem | Commercial: Novel Coronavirus test | Device ID: 299 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Northwell Health | Commercial: 2019 Novel Coronavirus PCR | Device ID: 300 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Novus Biologicals | Commercial: COVID19 IgG/IgM Rapid Test Kit | Device ID: 685 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: NY State Department of Health | Commercial: New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel | Device ID: 302 | Method: RT-PCR | Target: IgA, IgG, IgM, Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: OFM Medical | Commercial: OFM GmbH | Device ID: 2202 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: OPTOLANE Technologies Inc. | Commercial: Dr. PCR COVID-19 Viral Load 20K | Device ID: 303 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Orig3n | Commercial: Orig3n 2019 Novel Coronavirus (COVID-19) Test | Device ID: 742 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Paragon Genomics Inc. | Commercial: CleanPlex SARS-CoV-2 Research and Surveillance NGS Panel | Device ID: 305 | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Pardee lab | Commercial: En Carta SARS-CoV-2 | Device ID: 549 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: PaxGen Bio Co. Ltd. | Commercial: Dr. PCR COVID-19 Viral Load 20K | Device ID: 306 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: PCR BioSystems | Commercial: qPCRbio Probe 1-step-go Kit | Device ID: 887 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Pharmatech | Commercial: COVID19 IgG/IgM Rapid Test | Device ID: 686 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Phosphorus Diagnostics | Commercial: COVID-19 RT-qPCR Test | Device ID: 1407 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Pinpoint Science Inc. | Commercial: Pinpoint Covid-19 Screening Assay – Electrical detection of SARS-CoV-2 nucleocapsid protein using nanosensors and aptamer | Device ID: 312 | Method: Other | Target: Other | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PlexBio Co. Ltd. | Commercial: PlexBio CoVid19/SARS/Influenza A, B Detection kit | Device ID: 313 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Prantae Solutions Pte Ltd. | Commercial: EyeRa-Covid | Device ID: 314 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Predigen Inc. | Commercial: HR-PreV | Device ID: 315 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PREMIER MEDICAL CORPORATION PRIVATE LIMITED | Commercial: SureStatus COVID-19 (SARS-CoV-2) Card Test | Device ID: 317 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PREMIER MEDICAL CORPORATION PRIVATE LIMITED | Commercial: SureStatus COVID-19 (SARS-CoV-2) EIA Test | Device ID: 316 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: P4DETECT COVID-19 IgM/IgG | Device ID: 320 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: P4DETECT COVID-19 SAg | Device ID: 319 | Method: Immunoassay | 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