| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Advagen Biotech Ltd. | Commercial: COVID-19 IgG/IgM LF | Device ID: 818 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: AEHEALTH LIMITED | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2676 | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aesku.Diagnostics | Commercial: AESKULISA SARS-CoV-2 NP IgA | Device ID: 1091 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Aesku.Diagnostics | Commercial: AESKULISA SARS-CoV-2 NP IgG | Device ID: 1092 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Aesku.Diagnostics | Commercial: AESKULISA SARS-CoV-2 NP IgM | Device ID: 1093 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AESKU.DIAGNOSTICS GmbH & Co. KG | Commercial: AESKU.RAPID SARS-CoV-2 | Device ID: 2108 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: InfectCheck® - COVID-19 IgG/IgM Test | Device ID: 2136 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: InfectCheck® COVID-19 NAb Test | Device ID: 2137 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 Antigen Test | Device ID: 2130 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 IgG/IgM Test | Device ID: 2132 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 NAb Quantitative Test | Device ID: 2134 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AIDIAN | Commercial: Acro 2019-nCoV IgG/IgM pikatesti | Device ID: 994 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AIETech Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (AIE Fluorescence Immunochromatography) | Device ID: 3036 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 3022 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Immunochromatography) | Device ID: 3016 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Saliva) | Device ID: 3023 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit(Immunochromatography) | Device ID: 3017 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit(Nasal/Nasopharyngeal/Oropharyngeal/Saliva) | Device ID: 3024 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: AIVD Biotech Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) | Device ID: 18 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Akralab | Commercial: 2019nCoV IgG/IgM Rapid test Device | Device ID: 1002 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: DrivenFlow COVID-19 | Device ID: 21 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: Instant-view PLUS COVID-19 Test | Device ID: 958 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: Instant-view® PLUS COVID-19 Antigen Test | Device ID: 1678 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ALIMETRIX Inc. | Commercial: SARS-CoV-2 (COVID-19) serological test | Device ID: 1427 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ALLUM SRL | Commercial: DAILY TAMPON | Device ID: 1852 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AlphaBiolabs | Commercial: AlphaBiolabs IgM-IgG Combined Antibody Rapid Test | Device ID: 900 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Alphadia | Commercial: Alphadia | Device ID: 1803 | Method: Immunoassay | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Alphagen Bio-Technology Co.,Ltd | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 3965 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alphagen Bio-Technology Co.,Ltd | Commercial: SARS-CoV-2 Antigen Test Kit(Colloidal Gold) | Device ID: 3265 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Amazing Biotech (Shanghai) Co. Ltd. | Commercial: COVID-19 Antigen Sealing Tube Test Strip (Colloidal Gold) | Device ID: 2075 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 Ag | Device ID: 1304 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 IgG/IgM | Device ID: 993 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: Rapid Test SARS-CoV-2 Ag | Device ID: 1602 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Amedica SA | Commercial: Amela Covid-19 Antigen test | Device ID: 829 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amedica SA | Commercial: Amela Covid-19 IgM IgG Combo test kit | Device ID: 830 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) | Device ID: 2936 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER COVID-19 Neutralizing Antibody Rapid Testing kit (Colloidal Gold) | Device ID: 2873 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER RSV Antigen Rapid Test (Colloidal Gold) | Device ID: 2870 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: Quadruple Fast Test Pen (Latex) For SARS-CoV-2 & influenza A/B antigens and COVID-19 Neutralizing antibody | Device ID: 3579 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: RSV-SC2-Flu Quadruplex Fast Test (Colloidal Gold) For RSV SARS-CoV-2 & Influenza A/B antigens | Device ID: 5799 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: SC2Flu Triplex Fast Test (Colloidal Gold) For SARS-CoV-2 & influenza A/B antigens | Device ID: 2872 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Antigen Device | Device ID: 1203 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Antigen Device (Anterior Nasal Swab) | Device ID: 2605 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV IgG/IgM Device | Device ID: 1048 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2225 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: COVID-19 Antigen ELISA | Device ID: 1280 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Anbang (Xiamen) Biotechnology Co. Ltd. | Commercial: COVID-19 Hybrid Capture Fluorescence Immunoassay Test | Device ID: 32 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold )/ Saliva | Device ID: 2604 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold) | Device ID: 1822 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test（Colloidal Gold） | Device ID: 2239 | Method: Immunochromatography | 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