CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Anhui Formaster Biosci Co. Ltd. | Commercial: New Coronavirus (COVID-19) Antigen Rapid Test | Device ID: 2089 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: NG Biotech | Commercial: NG-Test SARS-CoV-2 Ag | Device ID: 1646 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: NG Biotech | Commercial: Ninonasal | Device ID: 1880 | Method: Immunochromatography | Target: Antigen | Format: 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: Bioscience(Tianjin) Diagnostic Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Rapid Detection kit | Device ID: 2858 | Method: RT-PCR | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Glallergen Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal gold immunochromatography) | Device ID: 2695 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Glallergen Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Test Kit (Latex Method) | Device ID: 4064 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) | Device ID: 2506 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Detection Kit | Device ID: 2684 | Method: Immunoassay | Target: | Format: | Go to details |
CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) | Device ID: 2588 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 1220 | 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: Yes | Manufacturer: Beijing Jinwofu Bioengineering Technology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit | Device ID: 2072 | 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: 1870 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Bionote Inc. | Commercial: NowCheck COVID-19 Ag Test | Device ID: 1242 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | Device ID: 2183 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 Ag Rapid Test | Device ID: 1581 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Abbott Rapid Diagnostics | Commercial: Panbio Covid-19 Ag Rapid Test | Device ID: 1232 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag (Nasopharyngeal Swab) | Device ID: 2271 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Zephyr Biomedicals-Tulip Diagnostics | Commercial: PerkinElmer COVID-19 Antigen Test (NS,NP) | Device ID: 2687 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lumigenex (Suzhou) Co. Ltd. | Commercial: PocRoc®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2128 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LumiQuick Diagnostics Inc. | Commercial: QuickProfile COVID-19 Antigen Test | Device ID: 1267 | 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: 1822 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: Rapid Gold Pro SARS-CoV-2 AG Test | Device ID: 3143 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test | Device ID: 1236 | 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: Xiamen Boson Biotech Co. Ltd. | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 1278 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 1481 | 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 | Device ID: 3099 | Method: Immunochromatography | Target: Antigen | Format: 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: Prognosis Biotech | Commercial: Rapid Test Ag 2019-nCov | Device ID: 1495 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: RAPIDAN TESTER Covid-19 Ag Test | Device ID: 1751 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor SARS-CoV-2 Rapid Ag Test | Device ID: 1443 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RAPIDNEXT™ SARS-CoV-2 Rapid Antigen Test Kit | Device ID: 4058 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidSens™ SARS-CoV-2 Rapid Antigen Test Kit | Device ID: 4059 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Sigmed Sp. z o.o. | Commercial: Redtest Professional Sars-CoV-2 Antigen Rapid Test (Covid-19 Ag) | Device ID: 2256 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: reOpenTest COVID-19 Antigen Rapid Test | Device ID: 1295 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Novatech | Commercial: SARS CoV-2 Antigen Rapid Test | Device ID: 1762 | 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 & Influenza A+B Antigen Combo Rapid Test Cassette | Device ID: 2063 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2233 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay) | Device ID: 5751 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | Device ID: 1769 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence) | Device ID: 1768 | Method: Immunochromatography | Target: Antigen | Format: Automated, 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: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test | Device ID: 2111 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test | Device ID: 2538 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Jucheng Medical Products Co. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test Kit | Device ID: 2979 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: SARS-CoV-2 Antigen (Colloidal Gold) | Device ID: 1820 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method) | Device ID: 2201 | Method: Immunoassay | Target: Antigen | Format: Manual | 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