| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Beijing Unidiag Technology Inc. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 3033 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: SARS-CoV-2 Total Ab ELISA | Device ID: 833 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold) | Device ID: 1485 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: WANTAI SARS-CoV-2 Ag Rapid Test (FIA) | Device ID: 1484 | Method: Other | Target: Antigen | Format: Lab-based, Manual, Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: Wantai SARS-CoV-2 IgM ELISA | Device ID: 834 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing WSWY Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography) | Device ID: 1362 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beroni Group | Commercial: SARS-CoV-2 IgG/igM Antibody Detection Kit | Device ID: 697 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BGI Europe A/S | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) | Device ID: 2988 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIO GROUP MEDICAL SYSTEM | Commercial: COVID-19 ANTIGEN RAPID TEST CASSETTE | Device ID: 2122 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bio-Rad Laboratories Inc. | Commercial: Platelia SARS-CoV-2 Total Ab Assay | Device ID: 756 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: (COVID-19) IgM/IgG Antibody Rapid Test Kit | Device ID: 2703 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: (COVID-19) IgM/IgG Antibody Rapid Test Kit (Latex Chromatography) | Device ID: 2706 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit | Device ID: 3079 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 2704 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) (anterior nasal swab) | Device ID: 3081 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography) | Device ID: 2705 | Method: Chromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit（Colloidal Gold） | Device ID: 2895 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2864 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Diagnostic Technology (Shandong) Co. Ltd. | Commercial: BIOBASE COVID-19 Antigen Rapid Test (Self-testing) | Device ID: 3112 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Diagnostic Technology (Shandong) Co. Ltd. | Commercial: BIOBASE COVID-19 Antigen Rapid Test（Self-Test） | Device ID: 3071 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocan Diagnostics Inc. | Commercial: Tell Me Fast COVID19 Antigen Test | Device ID: 2673 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocan Diagnostics Inc. | Commercial: Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test | Device ID: 524 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocheck GmbH | Commercial: Anti-SARS-CoV-2 IgG | Device ID: 1099 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biocomma limited | Commercial: biocomma®COVID-19 Antigen Test Kit | Device ID: 1687 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biocomma limited | Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit | Device ID: 1686 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioDetect (Xiamen) Biotechnology Co. Ltd. | Commercial: RAPID SARS-COV-2 ANTIGEN TEST CARD | Device ID: 3099 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioDetect (Xiamen) Biotechnology Co. Ltd. | Commercial: RAPID SARS-COV-2 ANTIGEN TEST CARD (self test) | Device ID: 2902 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biofeld Diagnostic and Lab Solutions INC. | Commercial: Biofeld Covid-19 Antigen Schnelltest | Device ID: 3504 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioGnost Ltd. | Commercial: CoviGnost AG Test Device 1x20 | Device ID: 2247 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BioGnost Ltd. | Commercial: CoviGnost AG test devices | Device ID: 2481 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: BOH-180 Fluorescent Immunoassay Analyzer | Device ID: 2694 | Method: Immunochromatography | Target: Antibody, Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay) | Device ID: 1293 | Method: ELISA | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Anterior Nasal Swab | Device ID: 2692 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Blood | Device ID: 2693 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method) | Device ID: 2230 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) | Device ID: 1286 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) | Device ID: 87 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOLAN HEALTH S.L. | Commercial: COVID-19 Antigen Rapid Test (Colloidal Gold Method) | Device ID: 2519 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOLAN HEALTH S.L. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1829 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biolidics | Commercial: 2019-nCoV IgG/IgM Antibody Detection Kit | Device ID: 497 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMARIC | Commercial: SARS-CoV-2 Total Ab ELISA | Device ID: 2639 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: BioMaxima SA | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 88 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMaxima SA | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2036 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMaxima SA | Commercial: SARS-CoV-2 Ag Rapid Test | Device ID: 2035 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgG | Device ID: 881 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgM | Device ID: 957 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: BioMedomics Inc. | Commercial: COVID-19 IgM/IgG Rapid Test | Device ID: 90 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMedomics Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (LFIA) | Device ID: 2520 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biomerica Inc. | Commercial: Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab) | Device ID: 1599 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biomerica Inc. | Commercial: Biomerica COVID-19 IgG/IgM Rapid Strip Test (1507B) | Device ID: 1603 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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