| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovation Biotechnology Co. Ltd. | Commercial: COVlD-19 IgM/IgG Antibodies Rapid Test(Colloidal GoId Method) | Device ID: 2055 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit | Device ID: 2046 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) | Device ID: 2044 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Double Antigen Sandwich Colloidal Gold Immunochromatography) | Device ID: 2048 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay) | Device ID: 2047 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV) -Antigentest | Device ID: 2292 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV) -Antigentest-Speichel | Device ID: 2293 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV)-Antigentest | Device ID: 2807 | Method: Immunochromatography | 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 Antibodies Test (Colloidal Gold) | Device ID: 2808 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) | Device ID: 2841 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) | Device ID: 1870 | Method: Immunochromatography | 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: 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: 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: 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 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: 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: 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: 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: 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 |
| CE Marking: Yes | Manufacturer: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2864 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Diagnostic Technology (Shandong) Co. Ltd. | Commercial: BIOBASE COVID-19 Antigen Rapid Test (Self-testing) | Device ID: 3112 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Diagnostic Technology (Shandong) Co. Ltd. | Commercial: BIOBASE COVID-19 Antigen Rapid Test（Self-Test） | Device ID: 3071 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | 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: BioDetect (Xiamen) Biotechnology Co. Ltd. | Commercial: RAPID SARS-COV-2 ANTIGEN TEST CARD | Device ID: 3099 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioDetect (Xiamen) Biotechnology Co. Ltd. | Commercial: RAPID SARS-COV-2 ANTIGEN TEST CARD (self test) | Device ID: 2902 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biofeld Diagnostic and Lab Solutions INC. | Commercial: Biofeld Covid-19 Antigen Schnelltest | Device ID: 3504 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: BOH-180 Fluorescent Immunoassay Analyzer | Device ID: 2694 | Method: Immunochromatography | Target: Antibody, 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: 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: 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: BioMaxima SA | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2036 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMaxima SA | Commercial: SARS-CoV-2 Ag Rapid Test | Device ID: 2035 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMedomics Inc. | Commercial: COVID-19 IgM/IgG Rapid Test | Device ID: 90 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMedomics Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (LFIA) | Device ID: 2520 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: Bioneovan COVID-19 Antigen Test Kit (Colloidal Gold) | Device ID: 2077 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: COVID-19 IgG Antibody Test Kit (Colloidal Gold) | Device ID: 2206 | Method: Immunochromatography | Target: IgG | Format: Lab-based, 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