CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
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 Testsea Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Cassette | Device ID: 1392 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Tongzhou Biotechnology Co Ltd | Commercial: SARS-CoV-2 Antigen Test(Nasal swab) | Device ID: 4108 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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 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: Healgen Scientific | Commercial: Rapid COVID-19 Antigen Test | Device ID: 1735 | Method: Immunoassay | 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: 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: 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: 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/Flu Ag Combo Test | Device ID: 1262 | Method: Immunoassay | Target: Antigen | 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: IEDAU INTERNATIONAL GMBH | Commercial: Covid-19 Antigen Schnelltest (Colloidales Gold) | Device ID: 2555 | Method: Immunoassay | 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 SARS-Cov2 Antigen Test | Device ID: 1791 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Innova Medical Group Inc. | Commercial: Innova SARS CoV-2 Antigen Rapid Qualitative Test | Device ID: 1801 | Method: Immunoassay | 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: Yes | Manufacturer: Innovative Diagnostics | Commercial: iD Rapid® COVID-19 Antigen | Device ID: 1728 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Ag Test (Latex Chromatography Assay) | Device ID: 1994 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Ag Test (Latex Chromatography Assay) (Anterior Nasal Swab) | Device ID: 2910 | Method: Immunoassay | 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: 3084 | 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 |
CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test (nasopharyngeal/nasal specimen) | Device ID: 1783 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Inzek International trading | Commercial: Biozek covid-19 Antigen Rapidtest BCOV-502 | Device ID: 1988 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: iXensor | Commercial: PixoTest® POCT COVID-19 Antigen Test | Device ID: 2217 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Baozhilin Medical Co Ltd | Commercial: SARS-COV-2 Antigen Rapid Test Kit | Device ID: 5754 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Device ID: 2107 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Other | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Device ID: 1264 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Diagnostics Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) | Device ID: 1920 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Diagnostics Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette(Nasopharyngeal/Oropharyngeal /Nasal) | Device ID: 2892 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Diagnostics Biotechnology Co. Ltd. | Commercial: COVID-19/Influenza A+B /RSV Antigen Combo Rapid Test Cassette(Colloidal Gold ) | Device ID: 5842 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1899 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) | Device ID: 2585 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) | Device ID: 3920 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal | Device ID: 2907 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal (self-test) | Device ID: 2658 | Method: Immunochromatography | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasopharyngeal | Device ID: 2887 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2-Virus-Antigen-Testkit (Kolloidales Gold) | Device ID: 2888 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Medomics medical technology Co. Ltd. | Commercial: SARS-CoV-2 antigen Test Kit (LFIA) | Device ID: 2006 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Medomics Medical Technology Co., Ltd | Commercial: SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) | Device ID: 3974 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Cassette | Device ID: 2586 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Cassette (Nasal Swab Specimen) | Device ID: 1644 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co. Ltd. | Commercial: COVID-19 Ag Rapid Test Device | Device ID: 2144 | 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