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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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2888 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Device ID: 2671 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 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva) Device ID: 1952 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 Antigen Saliva Lolly Test Device ID: 2740 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 Neutralizing Antibody Rapid Test Cassette Device ID: 2062 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. Commercial: 2019-nCoV Ab Test (Colloidal Gold) Device ID: 1000 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. Commercial: COVID-19 Antigen Test Kit (Colloidal Gold) Device ID: 1446 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. Commercial: COVID-19 IgG/IgM Combined Test kit(Colloidal Gold Method) Device ID: 995 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. Commercial: Covid-19 IgG/IgM test kit (Colloidal Gold Method) Device ID: 1001 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. Commercial: COVID-19 Test Kit (Colloidal Gold Method) Device ID: 2210 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. Commercial: COVID-19 Test Kit (Colloidal Gold Method)(for self-testing) Device ID: 2778 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. Commercial: COVID-19 Test Kit (Colloidal Gold Method)(Nasal Swab) Device ID: 2609 Method: Immunochromatography Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. Commercial: Singclean Device ID: 1974 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. Commercial: COVID-19 Antigen Test Cassette Device ID: 1392 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. Commercial: COVID-19 IgG/IgM Antibody Test(Colloidal Gold) Device ID: 1632 Method: Immunoassay Target: Antibody, IgG, IgM Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) Device ID: 857 Method: Immunoassay Target: Antibody, IgG, IgM Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. Commercial: New Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent PCR Method) Device ID: 215 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. Commercial: One Step SARS-nCoV2 (COVID-19) IgG/IgM test Device ID: 676 Method: Immunoassay Target: Antibody Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Hangzhou Tongzhou Biotechnology Co Ltd Commercial: SARS-CoV-2 Antigen Test(Nasal swab) Device ID: 4108 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Tongzhou Biotechnology Co Ltd Commercial: SARS-CoV-2 Antigen Test(nasopharyngeal swab) Device ID: 24766 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Zheda Dixun Biological Gene Engineering Co. Ltd. Commercial: SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Test Cassette (Swab) Device ID: 2942 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hayat Genetics Inc. Commercial: Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit Device ID: 1230 Method: LAMP Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Healgen Commercial: CLINITEST® Rapid COVID-19 Antigen Test Device ID: 2362 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Healgen Scientific Commercial: Clinitest Rapid Covid-19 Antigen Self Test Device ID: 2238 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Healgen Scientific Commercial: CLINITEST® Rapid COVID-19 Antigen Test Device ID: 2737 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Healgen Scientific Commercial: Coronavirus Ag Rapid Test Cassette Device ID: 1767 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Healgen Scientific Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Device ID: 677 Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Healgen Scientific Commercial: Rapid COVID-19 Antigen Test Device ID: 1735 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: No Manufacturer: Healgen Scientific Commercial: Rapid COVID-19 AntigenTest Device ID: 1612 Method: CLIA Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: Healvet Medtech GZ Ltd. Commercial: Healfo SARS-CoV-2 Ag Saliva Rapid Test Device ID: 2974 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hecin Scientific Inc. Commercial: COVID-19 IgM Antibody Rapid Test Kit Device ID: 478 Method: Immunoassay Target: Antibody, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hefei Biohit Healthcare Commercial: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method) Device ID: 1637 Method: Immunochromatography Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Henan UDX Biotechnology Co. Ltd. Commercial: UDXBIO Device ID: 2946 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: HGH Desinfections und Cosmetique GmbH Commercial: Covid-19 Slide Test Device ID: 1958 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hibergene Commercial: HG COVID-19 Device ID: 216 Method: LAMP Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Hibergene Commercial: PCR Adapt COVID-19 Device ID: 2739 Method: RT-PCR Target: Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Hipro Biotechnology Co. Ltd. Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) - Saliva Device ID: 2628 Method: Immunoassay Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: Hologic Commercial: Aptima SARS-CoV-2 Assay (Panther System) Device ID: 972 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Hologic Commercial: Panther Fusion SARS-CoV-2 assay Device ID: 217 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Hong Kong University of Science and Technology Commercial: On-site rapid molecular diagnostic system based on Shenzhen Shineway Technology Device ID: 218 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Hoyotek Biomedical Co. Ltd. Commercial: Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) Device ID: 1929 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hoyotek Biomedical Co. Ltd. Commercial: Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal gold) Device ID: 1930 Method: Immunoassay Target: Antibody, IgG, IgM Format: Manual Go to details
CE Marking: Yes Manufacturer: Hoyotek Biomedical Co. Ltd. Commercial: Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) Device ID: 1931 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hoyotek Biomedical Co.,Ltd, Commercial: Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) - self-testing Device ID: 3562 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Huachenyang (Shenzhen) Technology Co. Ltd. Commercial: 2019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25 Device ID: 1748 Method: Immunochromatography Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Huachenyang (Shenzhen) Technology Co. Ltd. Commercial: COVID-19 Ag Rapid Test Kit Device ID: 3153 Method: Immunochromatography Target: Antigen Format: Lab-based, Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Huachenyang (Shenzhen) Technology Co. Ltd. Commercial: COVID-19 lgM/lgG Antibody Diagnostic Kit(Colloidal Gold) Device ID: 2527 Method: Immunochromatography Target: Antibody, IgG, IgM Format: Manual Go to details
CE Marking: Yes Manufacturer: Hubei Jinjian Biology Co. Ltd. Commercial: SARS-CoV-2 Antigen Test Kit Device ID: 1759 Method: Immunochromatography Target: Antigen Format: Automated Go to details
CE Marking: Yes Manufacturer: Humasis Co. Ltd. Commercial: Celltrion DiaTrust ™– Covid-19 Ag Rapid Test Device ID: 2635 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Humasis Co. Ltd. Commercial: Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test Device ID: 5719 Method: Immunochromatography Target: Antibody, IgG, IgM Format: Manual Go to details
CE Marking: Yes Manufacturer: Humasis Co. Ltd. Commercial: Humasis COVID-19 Ag Home Test Device ID: 2276 Method: Immunochromatography 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