| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Ansh Labs | Commercial: SARS-CoV IgM ELISA | Device ID: 915 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Applied Biological Materials Inc. | Commercial: GenomeCov9 IgM/IgG Rapid Test Kit | Device ID: 917 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aripa Biotec GmbH | Commercial: Anti-SARS-CoV-2-Multi-Antikörper IgG/Nab-Test (IgG-Antikörper/neutralisierende Antikörper) (LFIA) | Device ID: 2633 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Artron Laboratories Inc. | Commercial: Artron COVID-19 IgM/IgG Antibody Test | Device ID: 1729 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 664 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody FIA | Device ID: 1577 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 1584 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ASSUT EUROPE SPA | Commercial: COVID-19 N.A.T. Neutralizing Antibodies Test | Device ID: 2195 | Method: Other | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical GmbH | Commercial: Atlas COVID-19 IgG/IgM Test Cassette | Device ID: 515 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical GmbH | Commercial: Atlas COVID-19 IgM Elisa Kit | Device ID: 773 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical GmbH | Commercial: Atlas COVID-19 S1-RBD IgG Elisa Kit | Device ID: 772 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical GmbH | Commercial: Atlas COVID-19 Total Antibody Elisa Kit | Device ID: 771 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Attana AB | Commercial: Attana AVA SARS-CoV-2 IgG Immunoassay | Device ID: 2335 | Method: Immunoassay | Target: Antibody | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Autobio Diagnostics Co. Ltd. | Commercial: Anti-SARS-CoV-2 Rapid Test | Device ID: 665 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Autobio Diagnostics Co. Ltd. | Commercial: SARS-CoV-2 IgG II CLIA Microparticles | Device ID: 919 | Method: CLIA | Target: Antibody | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: Anti-SARS-CoV-2 RBD CLIA Microparticles | Device ID: 2429 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: Anti-SARS-CoV-2 RBD ELISA | Device ID: 2430 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: SARS-CoV-2 NAb ELISA | Device ID: 2431 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 1912 | Method: Immunoassay | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: COVID-19 Neutralizing Antibody FIA | Device ID: 1910 | Method: Immunoassay | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: B-bio Co. Ltd. | Commercial: ChekR™ COVID-19 IgM/IgG Rapid test | Device ID: 1613 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: B-bio Co. Ltd. | Commercial: INNOGEN-B™ COVID-19 IgM/IgG Rapid test | Device ID: 1615 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: 2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method) | Device ID: 3048 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA) | Device ID: 3064 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Applied Biological Technologies Co. Ltd. | Commercial: SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method) | Device ID: 3065 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co. Ltd. | Commercial: 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P) | Device ID: 1359 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| 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 | 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: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Detection Kit (Competitive ELISA) | Device ID: 2045 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV IgG Antibody Determination Kit | Device ID: 63 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV IgG/IgM Antibody Rapid Test Kit | Device ID: 960 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co. Ltd. | Commercial: 2019-nCoV IgM Antibody Determination Kit | Device ID: 62 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold) | Device ID: 519 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology) | Device ID: 521 | Method: Immunoassay | Target: Antibody | 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(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 Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 IgG antibody ELISA Test Kit | Device ID: 69 | Method: ELISA | Target: Antibody | 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 | 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 | 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: 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 Tigsun Diagnostics Co. Ltd. | Commercial: Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) | Device ID: 77 | Method: Immunoassay | Target: Antibody | Format: 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: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: Wantai SARS-CoV-2 IgM ELISA | Device ID: 834 | Method: ELISA | Target: Antibody | Format: Automated, Manual | 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 | Format: Lab-based | 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