| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: 1drop Inc | Commercial: 1copy COVID-19 qPCR Kit | Device ID: 1 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: 3B BlackBio Biotech India Ltd | Commercial: TRUPCR SARS-CoV-2 RT qPCR Kit | Device ID: 3 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 3D Medicines | Commercial: 2019-nCoV RT-qPCR | Device ID: 2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 3D Medicines | Commercial: 3DMed 2019-nCoV RT-qPCR Detection Kit | Device ID: 4 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: A&B Professional | Commercial: A&B RAPID TEST COVID-19 IGG/IGM CASSETTA | Device ID: 1004 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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: Yes | Manufacturer: A. Menarini Diagnostics | Commercial: ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB) | Device ID: 1608 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AAZ | Commercial: Covid PRESTO Test rapide COVID-19 IgG/IgM | Device ID: 964 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AAZ | Commercial: PRESTO 2019-nCoV Direct qPCR Kit | Device ID: 963 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COV-QUANTO | Device ID: 1834 | Method: ELISA | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-PRESTO | Device ID: 1835 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-VIRO | Device ID: 1833 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY ABFlu-CoV-2 | Device ID: 2092 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Manual | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY RQ-2019-nCoV | Device ID: 2093 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY RQ-SARS-CoV-2 | Device ID: 2091 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA Srl | Commercial: REALQUALITY RQ-2019-nCoV | Device ID: 5 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AB Dianostic Systems GmbH | Commercial: abia SARS-CoV- IgG/IgM | Device ID: 913 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: Yes | Manufacturer: Abacus Diagnostica | Commercial: GenomEra SARS-CoV-2 | Device ID: 7 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: Abbott ID NOW COVID-19 | Device ID: 496 | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: ABBOTT REALTIME SARS-COV-2 ASSAY | Device ID: 876 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: Abbott RealTime SARS-CoV-2 EUA test | Device ID: 8 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Abbott | Commercial: BasePoint Covid-19 IgG/IgM Rapid test Device | Device ID: 1032 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Abbott | Commercial: COVID-19 LAB TEST TO DETECT ANTIBODIES | Device ID: 754 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: SARS-CoV-2 IgG | Device ID: 701 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Molecular Inc | Commercial: Abbott RealTime SARS-CoV-2 | Device ID: 1041 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Molecular Inc | Commercial: Alinity m SARS-CoV-2 AMP Kit | Device ID: 1042 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Rapid Diagnostics | Commercial: Panbio COVID-19 Ag Rapid Test | Device ID: 1232 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abingdon Health Plc | Commercial: AbC-19 Rapid Test | Device ID: 1992 | Method: Immunoassay | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Absea Biotechnology Ltd | Commercial: The non-invasive MEGA test of SARS-CoV-2 | Device ID: 9 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co., Ltd | Commercial: Absoludy COVID-19 IgM/IgG Combo | Device ID: 1302 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co., Ltd | Commercial: Absoludy COVID-19 IgM/IgG Rapid | Device ID: 1151 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co., Ltd. | Commercial: Absoludy COVID-19 Ag | Device ID: 1982 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co., Ltd. | Commercial: Absoludy COVID-19 Ag Rapid | Device ID: 1981 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Absology Co., Ltd. | Commercial: Absoludy COVID-19 NAb | Device ID: 1983 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC, Semi-automated | 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: Abwiz Bio | Commercial: RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA) | Device ID: 10 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Academia Sinica | Commercial: Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kit | Device ID: 11 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Academia Sinica | Commercial: SARS-CoV-2 Nucleocapsid Protein Rapid Detection Kit | Device ID: 12 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Access Bio, Inc | Commercial: CareStart COVID-19 IgM/IgG | Device ID: 506 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Access Bio, Inc | Commercial: CareStart COVID-19 MDx RT-PCR | Device ID: 760 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd | Commercial: Accu-Tell COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 14 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Accuster Technologies Pvt Ltd | Commercial: Accuster SARS-COV2-RT-PCR test kit | Device ID: 763 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Accuster Technologies Pvt Ltd | Commercial: COVID-19 RAPID IgG/IgM test kit | Device ID: 762 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: FIAflex SARS-CoV-2 Antigen FIA | Device ID: 1669 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: Foresight SARS-CoV-2 IgG | Device ID: 1424 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: Foresight SARS-CoV-2 IgM | Device ID: 1425 | Method: Immunoassay | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: Promotor SARS-CoV-2 RT-PCR Test Kit | Device ID: 1376 | Method: RT-PCR | Target: Nucleic acid | 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