| 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