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
2386 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Beijing Tigsun Diagnostics Co. Ltd Commercial: Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) Device ID: 77 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Commercial: SARS-CoV-2 Total Ab ELISA Device ID: 833 Method: ELISA Target: Antibody Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Commercial: Wantai SARS-CoV-2 Ab Rapid Test Device ID: 82 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Commercial: WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold) Device ID: 1485 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Commercial: WANTAI SARS-CoV-2 Ag Rapid Test (FIA) Device ID: 1484 Method: Other Target: Antigen Format: Lab-based, Manual, Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Commercial: Wantai SARS-CoV-2 IgM ELISA Device ID: 834 Method: ELISA Target: Antibody, IgM Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Commercial: Wantai SARS-CoV-2 RT-PCR Kit Device ID: 81 Method: RT-PCR Target: Nucleic acid Format: Manual 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: Beroni Group Commercial: SARS-CoV-2 IgG/igM Antibody Detection Kit Device ID: 697 Method: Immunoassay Target: Antibody, IgG, IgM Format: Lab-based Go to details
CE Marking: No Manufacturer: BGI Commercial: 2019-nCoV nucleic acid detection kit using combinatorial probe-anchor synthesis method Device ID: 83 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: BGI Commercial: Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 Device ID: 920 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: BillionToOne, Inc Commercial: qSanger-COVID-19 Assay Device ID: 1401 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Bio Basic Inc Commercial: SARS-CoV- RT-PCR Detection Kit Device ID: 921 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: BIO GROUP MEDICAL SYSTEM Commercial: COVID-19 ANTIGEN RAPID TEST CASSETTE Device ID: 2122 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Bio-Rad Laboratories / Zhejiang Orient Gene Biotech Commercial: Coronavirus Ag Rapid Test Cassette (Swab) Device ID: 2031 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: No Manufacturer: Bio-Rad Laboratories, Inc Commercial: Bio-Rad SARS CoV-2 ddPCR Assay Device ID: 541 Method: Digital-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Bio-Rad Laboratories, Inc Commercial: Platelia SARS-CoV-2 Total Ab Assay Device ID: 756 Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Bio-Techne Commercial: Ella / Simple Plex COVID-19 16×4 Standard Panel Device ID: 85 Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Bioantibody Biotechnology Co., Ltd. Commercial: (COVID-19) IgM/IgG Antibody Rapid Test Kit Device ID: 2703 Method: Chromatography Target: Antibody, IgG, IgM Format: Manual Go to details
CE Marking: Yes Manufacturer: Bioantibody Biotechnology Co., Ltd. Commercial: (COVID-19) IgM/IgG Antibody Rapid Test Kit (Latex Chromatography) Device ID: 2706 Method: Immunochromatography Target: IgG, IgM Format: Manual Go to details
CE Marking: Yes Manufacturer: Bioantibody Biotechnology Co., Ltd. Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) Device ID: 2704 Method: Chromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Bioantibody Biotechnology Co., Ltd. Commercial: SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography) Device ID: 2705 Method: Chromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Biocan Diagnostics Inc Commercial: Tell Me Fast COVID19 Antigen Test Device ID: 2673 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Biocan Diagnostics Inc Commercial: Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test Device ID: 524 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Biocartis Commercial: IdyllaTM SARS-COV-2 Test Device ID: 2662 Method: RT-PCR Target: Nucleic acid Format: Fully automated (robot) Go to details
CE Marking: Yes Manufacturer: Biocartis Commercial: IdyllaTM SARS-COV-2/FLU/RSV Panel Device ID: 2663 Method: RT-PCR Target: Format: Fully automated (robot) Go to details
CE Marking: No Manufacturer: Biocerna Commercial: SARS-CoV-2 Test Device ID: 708 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Biocheck GmbH Commercial: Anti-SARS-CoV-2 IgG Device ID: 1099 Method: Immunoassay Target: Antibody, IgG Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Biocomma limited Commercial: biocomma®COVID-19 Antigen Test Kit Device ID: 1687 Method: Chromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Biocomma limited Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit Device ID: 1686 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BioCore Commercial: BioCore 2019-nCoV Real Time PCR Kit Device ID: 1402 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Biodesix Commercial: Biodesix SARS-CoV-2 Droplet Digital PCR (ddPCR ) Test Device ID: 758 Method: Digital-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Biodesix Commercial: SARS-CoV-2 Droplet Digital PCR (ddPCR) test Device ID: 709 Method: Digital-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Bioeksen R&D Technologies Ltd Commercial: Bio-Speedy Direct RT-qPCR SARS-CoV-2 Device ID: 1060 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Bioeksen R&D Technologies Ltd Commercial: Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit Device ID: 525 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: BioFire Diagnostics Commercial: BioFire COVID-19 test Device ID: 710 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Biogate Laboratories Ltd Commercial: COVID-19 IgG/IgM Ab Rapid Test Device ID: 776 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Biogenix Inc Pvt Ltd Commercial: SARS CoV-2 IgG/IgM Ab Rapid Test Device ID: 777 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BioGnost Ltd Commercial: CoviGnost AG Test Device 1x20 Device ID: 2247 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: BioGnost Ltd Commercial: CoviGnost AG test devices Device ID: 2481 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: No Manufacturer: BioGX Commercial: SARS-CoV-2 in the Open System Reagents for BD MAX Device ID: 459 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: BIOHIT HealthCare (Hefei) Co., Ltd Commercial: SARS-CoV-2 Antigen Quantitative Assay Kit (Enzyme-linked Immunoassay) Device ID: 1293 Method: ELISA Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BIOHIT HealthCare (Hefei) Co., Ltd Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) Device ID: 1286 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: BIOHIT HealthCare (Hefei) Co., Ltd Commercial: SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) Device ID: 87 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Biohit Healthcare (Hefei) Co.,Ltd. Commercial: BOH-180 Fluorescent Immunoassay Analyzer Device ID: 2694 Method: Immunochromatography Target: Antigen Format: Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Biohit Healthcare (Hefei) Co.,Ltd. Commercial: SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Anterior Nasal Swab Device ID: 2692 Method: Immunochromatography Target: Antigen Format: Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Biohit Healthcare (Hefei) Co.,Ltd. Commercial: SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Blood Device ID: 2693 Method: Immunochromatography Target: Antigen Format: Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Biohit Healthcare (Hefei) Co.,Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method) Device ID: 2230 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BIOLAN HEALTH, S.L. Commercial: COVID-19 Antigen Rapid Test (Colloidal Gold Method) Device ID: 2519 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BIOLAN HEALTH, S.L. Commercial: COVID-19 IgG/IgM Rapid Test Cassette Device ID: 1829 Method: Immunoassay Target: Antibody, IgG, IgM 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