Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

Show advanced filters
Download as JSON, XML, CSV
291 records found
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