| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Spectrum for Diagnostic Industries | Commercial: (SDI) SARS-CoV-2 Qualitative Real Time PCR Kit | Device ID: 617 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Biomeme | Commercial: 10 Minutes COVID-19 IgG/IgM Rapid Test | Device ID: 92 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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: No | Manufacturer: Centers for Disease Control and Prevention | Commercial: 2019 nCoV Real-Time RT-PCR Diagnostic Panel | Device ID: 417 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Anitoa | Commercial: 2019 New Coronavirus (2019-nCoV) Test Kit | Device ID: 895 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co. Ltd. | Commercial: 2019 Novel Coronavirus (2019-nCoV) IgG Antibody Detection Kit (ELISA Method) | Device ID: 196 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou Darui Biotechnology Co. Ltd. | Commercial: 2019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method) | Device ID: 195 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Guangzhou HEAS BioTech Co. Ltd. | Commercial: 2019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method) | Device ID: 201 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag & Influenza A/B Rapid Co-DetectionKit (Immuno-Chromatography) | Device ID: 1342 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag & Influenza AB Ag RapidCo-Detection Kit (Immuno-Chromatography) | Device ID: 1323 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Biosearch Technologies | Commercial: 2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2 | Device ID: 733 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Beijing Shengkun Kangru Medical Equipment Co. Ltd. | Commercial: 2019-nCoV Detection kit (quantum dot immunofluorescence method) | Device ID: 78 | Method: Other | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Dan Wei Biotechnology Co. Ltd. | Commercial: 2019-nCoV Direct RT-qPCR Kit | Device ID: 213 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Intermedical SRL | Commercial: 2019-NCOV IGG/IGM | Device ID: 1011 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: TD diagnostics | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 1628 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: 2019-nCoV IgG/IgM Rapid Test Dipstick | Device ID: 674 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Nucleic Acid Detection Kit (Q-PCR Method) | Device ID: 1057 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: BGI | Commercial: 2019-nCoV nucleic acid detection kit using combinatorial probe-anchor synthesis method | Device ID: 83 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Beijing Kinhawk Pharmaceutical Co. Ltd. | Commercial: 2019-nCoV ORF1ab/N Gene Detection Kit (Fluorescence PCR Method) | Device ID: 73 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GenScript | Commercial: 2019-nCoV qRT-PCR Detection Assay | Device ID: 188 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Matridx Biotechnology Co. Ltd. | Commercial: 2019-nCov Rapid Test Kit | Device ID: 214 | Method: Immunoassay | Target: Antibody | Format: 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: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: 2019-Novel Coronavirus (2019 - nCoV) RT-PCR Detection Kit | Device ID: 358 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39501-Recombinant SARS-CoV-2 Nucleocapsid Protein | Device ID: 605 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39502-Recombinant SARS-CoV-2 Spike Protein | Device ID: 606 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39503-Recombinant SARS-CoV-2 Spike (R682S) Protein | Device ID: 607 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39504-Recombinant SARS-CoV-2 Envelope Protein | Device ID: 608 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39505-Recombinant SARS-CoV (2004) Nucleocapsid Protein | Device ID: 609 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39506-Recombinant MERS-CoV Nucleocapsid Protein | Device ID: 610 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39507-Recombinant Influenza A and B Ha Protein | Device ID: 611 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39508R-Sengenics Respiratory Virus Protein Microarray | Device ID: 612 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39509-Sengenics High-throughput, High Multiplex Microtitre Assay | Device ID: 613 | Method: Immunoassay | Target: Antibody, Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Star Array Ptd. Ltd. | Commercial: 8-minute RT-qPCR direct PCR testing system for SARS-CoV-2 detection | Device ID: 381 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: A*ccelerate | Commercial: A*STAR Fortitude Kit 2.0 | Device ID: 504 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: A*ccelerate | Commercial: A*STAR Fortitude Kit 2.0 (Singapore HSA) – PCR kit | Device ID: 13 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: AB Dianostic Systems GmbH | Commercial: abia SARS-CoV-2 Ab | Device ID: 505 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 NAb & TAb | Device ID: 1984 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 NAb Rapid | Device ID: 1985 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: AcouSort | Commercial: AB Blood plasma separation using ultrasound | Device ID: 649 | Method: Other | Target: Other | Format: Other | 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: Eachy Biopharmaceuticals | Commercial: AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay) | Device ID: 671 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: GeneTex International Corporation | Commercial: ACE2 antibody [N1N2], N-term (GTX101395) | Device ID: 557 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Acumen Research Laboratories Pte Ltd. | Commercial: Acu-Corona | Device ID: 16 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Acumen Research Laboratories Pte Ltd. | Commercial: Acu-Corona 2.0 | Device ID: 15 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: BIOTECON Diagnostics GmbH | Commercial: Acu-Corona 2.0/3.0 SARS-CoV-2 Real-time PCR Kits | Device ID: 530 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: ADTech Co. Ltd. | Commercial: ADTech COVID-19 Ag RAPID KIT | Device ID: 2736 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Aptamer Group Ltd. | Commercial: Adx SARS Cp V-2 Virus Antigen Rapid Point of Care Test | Device ID: 663 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Canary Health Technologies | Commercial: AiroStotleCV19 (Breath VOCs) | Device ID: 112 | Method: Other | Target: Other | Format: Other | 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