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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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2291 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: AUTOBIO DIAGNOSTICS., LTD. Commercial: Anti-SARS-CoV-2 RBD CLIA Microparticles Device ID: 2429 Method: CLIA Target: Antibody Format: Automated Go to details
CE Marking: Yes Manufacturer: AUTOBIO DIAGNOSTICS., LTD. Commercial: Anti-SARS-CoV-2 RBD ELISA Device ID: 2430 Method: ELISA Target: Antibody Format: Manual 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: AUTOBIO DIAGNOSTICS., LTD. Commercial: SARS-CoV-2 NAb ELISA Device ID: 2431 Method: ELISA Target: Antibody Format: Manual Go to details
CE Marking: Yes Manufacturer: AUTOBIO DIAGNOSTICS., LTD. Commercial: SARS-CoV-2 NAb Q CLIA Microparticles Device ID: 2232 Method: CLIA Target: Antibody Format: Automated Go to details
CE Marking: Yes Manufacturer: Avacta Life Sciences Ltd Commercial: AffiDX SARS-CoV-2 Antigen Lateral Flow Test Device ID: 2426 Method: Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: AVALUN SAS Commercial: Ksmart® SARS-COV2 Antigen Rapid Test Device ID: 1800 Method: Immunochromatography Target: Antigen Format: Semi-automated Go to details
CE Marking: No Manufacturer: Avellino Lab Commercial: Avellino SARS-CoV-2/COVID-19 (AvellinoCoV2) Device ID: 48 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Avioq Bio-Tech Co., Ltd Commercial: Novel Coronavirus (2019-nCov)Antibody IgG/IgM Assay Kit (Colloidal Gold) Device ID: 47 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Avioq Bio-Tech Co., Ltd Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold) Device ID: 1972 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: AXIOM Gesellschaft für Diagnostica und Biochemica mbH Commercial: COVID-19 Antigen Rapid Test Device ID: 2101 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AXIOM Gesellschaft für Diagnostica und Biochemica mbH Commercial: COVID-19 Antigen Saliva Test Device ID: 2476 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Axium Bioresearch Inc Commercial: AxiumHealth COVID-19 IgG/IgM Antibody Test Device ID: 775 Method: Immunoassay Target: Antibody Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc Commercial: COVID-19 Antigen Rapid Test Device Device ID: 1906 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc Commercial: COVID-19 Antigen Saliva Test Kit Device ID: 1911 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc Commercial: COVID-19 IgG/IgM Rapid Test Device Device ID: 1912 Method: Immunoassay Target: Antibody, IgG, IgM Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc Commercial: COVID-19 Neutralizing Antibody FIA Device ID: 1910 Method: Immunoassay Target: Antibody Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Azure Biotech Inc Commercial: Dia Sure COVID-19 Antigen Rapid Test Device Device ID: 2382 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Azure Biotech, Inc. Commercial: Dia Sure COVID-19 Antigen Rapid Test Device Device ID: 2060 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: B-bio Co., Ltd. Commercial: ChekR™ COVID-19 IgM/IgG Rapid test Device ID: 1613 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: B-bio Co., Ltd. Commercial: INNOGEN-B™ COVID-19 IgM/IgG Rapid test Device ID: 1615 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BAG Diagnostics Commercial: Viro-Q SARS-CoV-2 kit Device ID: 703 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Baicare(Tianjin) Biotechnology Co,. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Device ID: 2602 Method: Immunochromatography Target: Antigen Format: Lab-based, Manual Go to details
CE Marking: No Manufacturer: Baiya Phytopharm, Co., Ltd Commercial: Baiya Rapid COVID-19 IgM/IgG test kit Device ID: 50 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Bako Diagnostics Commercial: BakoDx SARS-CoV-2 RNA test Device ID: 704 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Bakter Medical s.r.o. Commercial: Saligen Device ID: 1782 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Bao Ruiyuan Biotech (Beijing) Co., Ltd Commercial: Novel Coronavivus(2019-nCov)Nucleic Acid Detection Kit-Multiple Fluorescence PCR Device ID: 51 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: BBB Inc. Commercial: MARK-B COVID-19 Ag Device ID: 2315 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BBB INC; Obelis S.A.(BE) Commercial: MARK-B COVID-19 Ag S Device ID: 1234 Method: Immunoassay Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Becton Dickinson Commercial: BD Kit For Rapid Detection of SARS-CoV-2 Device ID: 2282 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Becton Dickinson Commercial: BD SARS-CoV-2 Reagents for BD MAX System Device ID: 706 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Becton Dickinson Commercial: BD Veritor™ System for Rapid Detection of SARS CoV 2 Device ID: 1065 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Becton Dickinson Commercial: BioGX SARS-CoV-2 Reagents for BD MAX System Device ID: 518 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Beijing Abace Biology Co., Ltd Commercial: COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) Device ID: 1281 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Abace Biology Co., Ltd Commercial: COVID-19 Viral Antigen Test Kit (ELISA) Device ID: 1282 Method: ELISA Target: Antigen Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Applied Biological Technologies Co., Ltd Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV (manual & automated lab-based) Device ID: 57 Method: RT-PCR Target: Nucleic acid Format: Automated, Lab-based, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Beier Bioengineering Co., Ltd Commercial: 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P) Device ID: 1359 Method: Immunoassay Target: Antibody, IgG, IgM Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Beier Bioengineering Co., Ltd Commercial: Covid-19 Antigen Rapid Test Kit Device ID: 1310 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Beier Bioengineering Co., Ltd Commercial: MediPort Limited Device ID: 1969 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: No Manufacturer: Beijing Beier Bioengineering Co., Ltd Commercial: Multiple Real-Time PCR Kit for Detection of 2019-nCoV Device ID: 58 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Beier Bioengineering Co.,Ltd Commercial: Covid-19 Antigen Rapid Test Kit Device ID: 2653 Method: Immunochromatography Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: Beijing Beier Bioengineering Co.,Ltd Commercial: Covid-19 Antigen Rapid Test Kit (Colloidal Gold) Device ID: 2667 Method: Immunochromatography Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: Beijing Beier Bioengineering Co.Ltd. Commercial: COVID-19 ANTIGEN RAPID TEST KIT Device ID: 2326 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: No Manufacturer: Beijing Biochem Hengye Science & Technology Development Co., Ltd Commercial: SARS-CoV-2 Real-Time RT-PCR Kit Device ID: 59 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Beijing Bohui Innovation Biotechnology Commercial: Fully Automated 26 Plex RES Panel Assay Device ID: 60 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Beijing Bohui Innovation Biotechnology Commercial: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Microfluidic Chip) Device ID: 61 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Beijing Bohui Innovation Biotechnology Co., Ltd. Commercial: COVlD-19 IgM/IgG Antibodies Rapid Test(Colloidal GoId Method) Device ID: 2055 Method: Immunochromatography Target: Antibody, IgG, IgM Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Beijing Bohui Innovative Biotechnology Co., Ltd. Commercial: Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit Device ID: 2046 Method: Immunochromatography Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Bohui Innovative Biotechnology Co., Ltd. Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) Device ID: 2044 Method: Immunochromatography Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Bohui Innovative Biotechnology Co., Ltd. Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Double Antigen Sandwich Colloidal Gold Immunochromatography) Device ID: 2048 Method: Immunochromatography Target: Antibody Format: Automated, 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