| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test (self test) | Device ID: 3136 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette (Nasal Swab) | Device ID: 1610 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette(Saliva) | Device ID: 1746 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co. Ltd. | Commercial: COVID-19/Influenza A+B Antigen Combo Rapid Test | Device ID: 1365 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid RT-PCR Test Kit | Device ID: 1364 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Dan Wei Biotechnology Co. Ltd. | Commercial: 2019-nCoV Direct RT-qPCR Kit | Device ID: 213 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Deangel Biological Engineering Co. Ltd. | Commercial: Novel Coronavirus S Glycoprotein Detection Kit | Device ID: 1259 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Dian Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Cassette | Device ID: 2629 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Dian Biotechnology Co. Ltd. | Commercial: Real-time RT-PCR Detection Kit For 2019-nCoV | Device ID: 569 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Fanttest Biotech Co Ltd | Commercial: SARS-CoV-2/RSV/Adenovirus/Influenza A+B Antigen Combo Rapid Test Kit | Device ID: 25663 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Fanttest Biotech Co Ltd | Commercial: SARS-CoV-2/RSV/Influenza A+B Antigen Combo Rapid Test Kit | Device ID: 25662 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Fanttest Biotech Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette | Device ID: 2153 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Fanttest Biotech Co.,Ltd. | Commercial: SARS-CoV-2/RSV/Adenovirus/M.pneumoniae/ Influenza A+B Antigen Combo Rapid Test Kit | Device ID: 25664 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Funworld Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Device | Device ID: 2862 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Genesis Biodetection & Biocontrol Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 1261 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd. | Commercial: KaiBiLi COVID-19 Antigen | Device ID: 2085 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd. | Commercial: KaiBiLi COVID-19 Antigen Pro | Device ID: 2885 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd. | Commercial: KaiBiLi Flu & COVID-19 Antigen Duo | Device ID: 2890 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Immuno Biotech Co. Ltd. | Commercial: Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive) | Device ID: 1844 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Immuno Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2317 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Jucheng Medical Products Co. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test Kit | Device ID: 2979 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co. Ltd. | Commercial: COVID-19 and Influenza A/B Antigen Test Kit | Device ID: 5818 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co. Ltd. | Commercial: LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) | Device ID: 1215 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co. Ltd. | Commercial: LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | Device ID: 477 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) - (saliva, sputum) | Device ID: 2634 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Testkit (Colloidal Gold | Device ID: 2224 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou LifeReal Biotechnology Co. Ltd. | Commercial: LifeReady 1000 automatic integrated gene detection system | Device ID: 2556 | Method: RT-PCR | Target: | Format: Automated, Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device（Colloidal Gold） | Device ID: 2139 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Rapid Test Device（Colloidal Gold） | Device ID: 2142 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. | Commercial: nCoV-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum) | Device ID: 2141 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. | Commercial: The COVID-19 Antigen Rapid Test Device (Colloidal Gold) | Device ID: 3949 | Method: | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hangzhou Matridx Biotechnology Co. Ltd. | Commercial: 2019-nCov Rapid Test Kit | Device ID: 214 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: 2019-nCOV IgG/LgM Rapid Test Device | Device ID: 570 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: 2019-nCoV-IgG Assay Reagent Kit (CMIA) | Device ID: 1793 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: 2019-nCoV-IgM Assay Reagent Kit (CMIA) | Device ID: 1794 | Method: Immunoassay | Target: IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography) | Device ID: 1795 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen rapid test | Device ID: 1743 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 1220 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) | Device ID: 2018 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) (self-test) | Device ID: 3027 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) | Device ID: 1796 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus Neutralizing Antibody Assay Reagent Kit | Device ID: 1802 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel coronavirus neutralizing antibody Rapid Test Device | Device ID: 1896 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）（self-test） | Device ID: 3116 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab) | Device ID: 1789 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd. | Commercial: SARS-Cov-2＆Influenza A/B Combo Rapid Test Cassette (swab) | Device ID: 3964 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1970 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: GENnasal SARS-CoV.2 Antigen Rapid Test | Device ID: 3146 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette | Device ID: 2063 | Method: Immunoassay | 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 | Device ID: 1945 | Method: Immunochromatography | 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