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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

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305 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Device ID: 1284 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 Antigen Rapid Test Kit (FIA) Device ID: 70 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) Device ID: 1285 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing O&D Biotech Co. Ltd. Commercial: COVID-19 Antigen Rapid Test Device ID: 2494 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Savant Biotechnology Co. Ltd. Commercial: SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit Device ID: 1235 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Strong Biotechnologies Inc. Commercial: SARS-CoV-2 Antigen Test Device ID: 3722 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. Commercial: Tigsun COVID-19 Antigen Rapid Test Device ID: 1292 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. Commercial: Tigsun COVID-19 Antigen Saliva Rapid Test Device ID: 1290 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing WSWY Technology Co. Ltd. Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography) Device ID: 1362 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Bioantibody Biotechnology Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) (anterior nasal swab) Device ID: 3081 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Biomerica Inc. Commercial: Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab) Device ID: 1599 Method: Immunoassay 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: BIOTEKE CORPORATION (WUXI) Co. Ltd. Commercial: SARS-CoV-2 Antigen Test Kit (colloidal gold method) Device ID: 2067 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. Commercial: SARS-CoV-2 Antigen Test Kit (colloidal gold method) nasal swab Device ID: 2068 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Bioteke Taizhou Biotechnology Co. Ltd. Commercial: SARS-CoV-2 Antigen Test Kit (colloidal gold method) Device ID: 1487 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BioVendor Commercial: BIOCREDIT COVID-19 Ag Device ID: 335 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Birmingham Biotech Ltd. Commercial: BHM COVID-19 Antigen Rapid Test Device ID: 3008 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Birmingham Biotech Ltd. Commercial: BHM COVID-19 Antigen Sealing Tube Test Strip Device ID: 3007 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Blue Cross Bio-Medical(Beijing) Co. Ltd. Commercial: COVID-19 Antigen Test Device ID: 2627 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: BMT Diagnostics Commercial: Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab) Device ID: 1605 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BN Santé Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) Device ID: 1828 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Boditech Med Inc. Commercial: AFIAS COVID-19 Ag Device ID: 1989 Method: Immunoassay Target: Antigen Format: Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Boditech Med Inc. Commercial: AFIAS COVID-19/Flu Ag Combo Device ID: 1449 Method: Immunoassay Target: Antigen Format: Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: BTNX Inc. Commercial: Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid) Device ID: 1684 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Camtech Commercial: COVID-19 Viral Antigen Test Kit Device ID: 1237 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Canary Global Inc. Commercial: Pelican COVID-19 Ultra-Rapid Mobile Test Device ID: 2283 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. Commercial: CHECK UP SARS-COV-2 NASAL ANTIGEN RAPID TEST Device ID: 2696 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi Commercial: CHIL COVID-19 Antigen Rapid Test Device ID: 3864 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi Commercial: CHIL COVID-19 Antigen Rapid Test (Nasal / Nasopharyngeal / Oropharyngeal Swab-Casette) Device ID: 1691 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Chongqing Novegent Biotech Company Limited Commercial: Novegent COVID-19 Antigen Rapid Test Kit Device ID: 1189 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) Device ID: 2437 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test Cassette Device ID: 1471 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: COVID-19 Antigen Rapid Test Device ID: 1387 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: COVID-19 Antigen Rapid Test (For Reader) Device ID: 1480 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: COVID-19 Antigen Rapid Test (Swab) Device ID: 2449 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)(FIA) Device ID: 2388 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: COVID-19 Antigen Test for Self Testing Device ID: 1476 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test Device ID: 1474 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Device ID: 1472 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: CITEST DIAGNOSTICS Inc. Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test Device ID: 1473 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Core Technology Co. Ltd. Commercial: Antigen Rapid Test COVID-19 Coretests Device ID: 1594 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Coris BioConcept Commercial: COVID-19 Ag Respi-Strip Device ID: 133 Method: Immunoassay Target: Antigen Format: Near POC / POC 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: DDS DIAGNOSTIC SRL Commercial: Test Rapid Combo Covid-19/Influenza A+B Antigen Device ID: 1305 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: DDS DIAGNOSTIC SRL Commercial: Test Rapid Combo Covid-19/Influenza A+B Antigen (tampon nazofaringian)) Device ID: 1226 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. Commercial: OneStep COVID-19 Antigen RapiCard InstaTest Device ID: 1195 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: DIAsource ImmunoAssays Commercial: COVID-19 Antigen Rapid Test Device ID: 1792 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: DNA Diagnostic Commercial: SARS-CoV-2 Antigen Rapid Test Device ID: 2756 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: DS Bio and Nano Technology Product Tracking Verification Corp. Commercial: DS AntijenX Device ID: 2551 Method: Immunoassay Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: DyonMed SA Commercial: CORONA-Ag Device ID: 1662 Method: Immunoassay 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