CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 1945 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2671 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva) | Device ID: 1952 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 Antigen Saliva Lolly Test | Device ID: 2740 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Colloidal Gold) | Device ID: 1446 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: COVID-19 Test Kit (Colloidal Gold Method) | Device ID: 2210 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: COVID-19 Test Kit (Colloidal Gold Method)(for self-testing) | Device ID: 2778 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: COVID-19 Test Kit (Colloidal Gold Method)(Nasal Swab) | Device ID: 2609 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: Singclean | Device ID: 1974 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Tongzhou Biotechnology Co Ltd | Commercial: SARS-CoV-2 Antigen Test(nasopharyngeal swab) | Device ID: 24766 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Zheda Dixun Biological Gene Engineering Co. Ltd. | Commercial: SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Test Cassette (Swab) | Device ID: 2942 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Healgen | Commercial: CLINITEST® Rapid COVID-19 Antigen Test | Device ID: 2362 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: Clinitest Rapid Covid-19 Antigen Self Test | Device ID: 2238 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: CLINITEST® Rapid COVID-19 Antigen Test | Device ID: 2737 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: Coronavirus Ag Rapid Test Cassette | Device ID: 1767 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Healvet Medtech GZ Ltd. | Commercial: Healfo SARS-CoV-2 Ag Saliva Rapid Test | Device ID: 2974 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hefei Biohit Healthcare | Commercial: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method) | Device ID: 1637 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co. Ltd. | Commercial: Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) | Device ID: 1929 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co. Ltd. | Commercial: Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) | Device ID: 1931 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co.,Ltd, | Commercial: Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) - self-testing | Device ID: 3562 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Huachenyang (Shenzhen) Technology Co. Ltd. | Commercial: 2019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25 | Device ID: 1748 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
CE Marking: Yes | Manufacturer: Huachenyang (Shenzhen) Technology Co. Ltd. | Commercial: COVID-19 Ag Rapid Test Kit | Device ID: 3153 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Huachenyang (Shenzhen) Technology Co. Ltd. | Commercial: COVID-19 lgM/lgG Antibody Diagnostic Kit(Colloidal Gold) | Device ID: 2527 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hubei Jinjian Biology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 1759 | Method: Immunochromatography | Target: Antigen | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Celltrion DiaTrust ™– Covid-19 Ag Rapid Test | Device ID: 2635 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test | Device ID: 5719 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19 Ag Home Test | Device ID: 2276 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19 Ag Test | Device ID: 1263 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19 IgG/IgM Test | Device ID: 219 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Hunan Yonghe-Sun Biotechnology Co. Ltd. | Commercial: SARS-COV-2 specific antibody test kit (Immunochromatography) | Device ID: 221 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hunan Zhongke Lanhai Biotechnology Co. Ltd. | Commercial: OJABIO SARS-CoV-2 Antigen Detection Test Kit (Colloidal Gold Method) | Device ID: 1575 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hunan Zhongke Lanhai Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Test Kit (Colloidal Gold Method) | Device ID: 3018 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-CoV Ag Saliva Rapid Test Card | Device ID: 2470 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-nCoV Ag Rapid Test Kit | Device ID: 2473 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-nCoV IgG&IgM Antibody Rapid Test Kit | Device ID: 2474 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Immundiagnostik AG | Commercial: PreventID ® SARS-CoV-2-Antigen | Device ID: 2815 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ImmunoDiagnostics Limited | Commercial: COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography) | Device ID: 2265 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid New Coronavirus (COVID19) IgG/IgM Combo Test | Device ID: 1903 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid New Coronavirus (COVID19) Neutralizing Antibody Test | Device ID: 1904 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid SARS-Cov2 Antigen Test | Device ID: 1791 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: InBios International | Commercial: SCoV-2 Ag Detect Rapid Test | Device ID: 1421 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) | Device ID: 2332 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2331 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2278 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Innovation Scientific Pty Ltd. | Commercial: InnoScreenTM COVID-19 IgG/IgM Rapid Test Device | Device ID: 2565 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Neutralizing Antibody Test (Quantum Dot Immunofluorescence Chromatography) | Device ID: 2531 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: AQ+ COVID-19 Ag Rapid Test | Device ID: 3084 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: AQ+ COVID-19 Ag Rapid Test | Device ID: 3098 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test | Device ID: 2484 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen) | Device ID: 2419 | 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