| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva | Device ID: 1798 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus(SARS-CoV-2) Neutralizing AntibodiesTest (Up-converting Phosphor Immunochromatographic Technology) | Device ID: 2809 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: SARS-CoV-2 (S-RBD & NP) Antibody Test (Colloidal Gold) | Device ID: 2811 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: SARS-CoV-2 and Flu A/B Antigen Combo Rapid Test (Colloidal Gold) | Device ID: 2810 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Jinwofu Bioengineering Technology Co. Ltd. | Commercial: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test | Device ID: 1725 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Jinwofu Bioengineering Technology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit | Device ID: 2072 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: COVID19 Antigen Rapid Test Kit | Device ID: 1778 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit | Device ID: 707 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1284 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (FIA) | Device ID: 70 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) | Device ID: 1285 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 IgG antibody ELISA Test Kit | Device ID: 69 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 IgG/IgM antibody Rapid Test Kit (Colloidal Gold) | Device ID: 71 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 IgM antibody ELISA Test Kit | Device ID: 67 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 total antibody ELISA Test Kit | Device ID: 1111 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 total antibody rapid test | Device ID: 1112 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1790 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: 2019-nCoV antigen, Influenza A virus antigen, Influenza B virus antigen detection kit (colloidal gold immunochromatography) | Device ID: 3078 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) | Device ID: 523 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1331 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) | Device ID: 2881 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing North Institute of Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 3009 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing North Institute of Biotechnology Co. Ltd. | Commercial: COVID-19 TEST RAPIDO ANTIGENE RICOV4 | Device ID: 2733 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing O&D Biotech Co. Ltd. | Commercial: Coronavirus disease (COVID-19) Total Antibody Rapid Test (Colloidal Gold) | Device ID: 667 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing O&D Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2494 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Savant Biotechnology Co. Ltd. | Commercial: Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography) | Device ID: 76 | Method: Immunochromatography | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Savant Biotechnology Co. Ltd. | Commercial: SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit | Device ID: 1235 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Strong Biotechnologies Inc. | Commercial: SARS-CoV-2 Antigen Test | Device ID: 3722 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. | Commercial: Tigsun COVID-19 Antigen Rapid Test | Device ID: 1292 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Tigsun Diagnostics Co. Ltd. | Commercial: Tigsun COVID-19 Antigen Saliva Rapid Test | Device ID: 1290 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| 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 Unidiag Technology Inc. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 3033 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: 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: Yes | Manufacturer: BGI Europe A/S | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) | Device ID: 2988 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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 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 | Device ID: 3079 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) (anterior nasal swab) | Device ID: 3081 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit（Colloidal Gold） | Device ID: 2895 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based, 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