CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Bakter Medical s.r.o. | Commercial: Saligen | Device ID: 1782 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BBB Inc. | Commercial: MARK-B COVID-19 Ag | Device ID: 2315 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BBB Inc. Obelis S.A.(BE) | Commercial: MARK-B COVID-19 Ag S | Device ID: 1234 | Method: Immunoassay | Target: Antigen | Format: Other | Go to details |
CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG | Device ID: 2996 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG (1st IS) | Device ID: 2994 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG II | Device ID: 2995 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgM | Device ID: 2997 | Method: CLIA | Target: IgM | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD Kit For Rapid Detection of SARS-CoV-2 | Device ID: 2282 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD Veritor™ System for Rapid Detection of SARS CoV 2 | Device ID: 1065 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Abace Biology Co. Ltd. | Commercial: COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1281 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Abace Biology Co. Ltd. | Commercial: COVID-19 Viral Antigen Test Kit (ELISA) | Device ID: 1282 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Cassette | Device ID: 3068 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Cassette Anterior Nasal Swab | Device ID: 3058 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab | Device ID: 3062 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Cassette Saliva | Device ID: 3060 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method) | Device ID: 3048 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 6 Respiratory Pathogen Antigens Rapid Test Cassette (Colloidal Gold Method) | Device ID: 3047 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette For self-testing use only | Device ID: 3167 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 3044 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2839 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Anterior Nasal Swab | Device ID: 3059 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Nasopharyngeal and Oropharyngeal Swab | Device ID: 3063 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Saliva | Device ID: 3061 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA) | Device ID: 3064 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method) | Device ID: 3065 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co. Ltd. | Commercial: 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P) | Device ID: 1359 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit | Device ID: 2769 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co. Ltd. | Commercial: COVID-19 ANTIGEN RAPID TEST KIT | Device ID: 2326 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co. Ltd. | Commercial: Covid-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2667 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co. Ltd. | Commercial: MediPort Limited | Device ID: 1969 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Bohui Innovation Biotechnology Co. Ltd. | Commercial: COVlD-19 IgM/IgG Antibodies Rapid Test(Colloidal GoId Method) | Device ID: 2055 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit | Device ID: 2046 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) | Device ID: 2044 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Double Antigen Sandwich Colloidal Gold Immunochromatography) | Device ID: 2048 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay) | Device ID: 2047 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Detection Kit (Competitive ELISA) | Device ID: 2045 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: No | Manufacturer: Beijing Decombio Biotechnology | Commercial: Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette | Device ID: 666 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) | Device ID: 1283 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV IgG Antibody Determination Kit | Device ID: 63 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV IgG/IgM Antibody Rapid Test Kit | Device ID: 960 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV IgM Antibody Determination Kit | Device ID: 62 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 3622 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV) -Antigentest | Device ID: 2292 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV) -Antigentest-Speichel | Device ID: 2293 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV)-Antigentest | Device ID: 2807 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold) | Device ID: 519 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology) | Device ID: 521 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) | Device ID: 2808 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) | Device ID: 1870 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) | Device ID: 2841 | 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