| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: No | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Device ID: 735 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Ebram Produtos Laboratoriais Ltd. | Commercial: CORONAVÍRUS IgG/IgM (COVID-19) | Device ID: 543 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spark Diagnostics LLC | Commercial: CoV-Check - COVID-19 IgG/IgM Test | Device ID: 1086 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spark Diagnostics LLC | Commercial: CoV-Check DIRECT Covid-19 Antigen Test | Device ID: 1196 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ARDİ MEDİKAL ARAŞTIRMA VE DİAGNOSTİK ÜRÜNLERİ SAN. TİC. LTD. ŞTİ. | Commercial: CoVard Covid-19 Nasal Antigen Test Kit | Device ID: 3568 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ARDİ MEDİKAL ARAŞTIRMA VE DİAGNOSTİK ÜRÜNLERİ SAN. TİC. LTD. ŞTİ. | Commercial: CoVard Covid-19 Rapid Antigen Test Kit | Device ID: 4000 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EMBIO Diagnostics Ltd. | Commercial: CovBELD | Device ID: 1313 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tauschen Int. Ltd. (Tauschen Groups) | Commercial: COVID - 19 RAPID TEST KIT / Antibody IgG & IgM Test Kit | Device ID: 620 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Neo Nostics (Suzhou) Bioingeneering Co. Ltd. | Commercial: COVID 19 Antigen Test Kit (Colloidal Gold Method) | Device ID: 2608 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: No | Manufacturer: Medsource Ozone Biomedicals | Commercial: COVID 19 IgG IgM Rapid Test | Device ID: 583 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AAZ | Commercial: Covid PRESTO Test rapide COVID-19 IgG/IgM | Device ID: 964 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: InDevR Inc. | Commercial: COVID Serology Kit: Multiplexed Immunoassay | Device ID: 225 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology Co. Ltd. | Commercial: COVID-19 & Influenza A+B Antigen Combo Test Kit (Colloidal Gold) | Device ID: 1354 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 & Influenza A/B Antigen Combo Test Device | Device ID: 1371 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 & Influenza A/B Antigen Nasal Test Kit | Device ID: 3106 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 & Influenza A/B Nucleic Acid Combo Test | Device ID: 1373 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 & M. pneumoniae Antigen Combo Test Device | Device ID: 1372 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) | Device ID: 1830 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. | Commercial: COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold) - (Nasal swab/saliva) | Device ID: 1589 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. | Commercial: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit | Device ID: 510 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Labnovation Technologies Inc. | Commercial: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit | Device ID: 577 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 + Flu A&B + RSV + Adenovirus Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab) | Device ID: 1892 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 + Flu A&B + RSV Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab) | Device ID: 1891 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab) | Device ID: 1877 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Coris BioConcept | Commercial: COVID-19 Ag Respi-Strip | Device ID: 133 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test | Device ID: 1256 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ulti Med Products GmbH | Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 1391 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2391 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 2437 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test Cassette | Device ID: 1471 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: COVID-19 and Influenza A+B Rapid Antigen Combo Test | Device ID: 2845 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test | Device ID: 1386 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test | Device ID: 1698 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2435 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test (Whole Blood/Serum/Plasma) Package Insert | Device ID: 2420 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo | Device ID: 1385 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test | Device ID: 1697 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2412 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2436 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antibody Detection Kit | Device ID: 2306 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit | Device ID: 1939 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit (QDs) | Device ID: 1940 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: FemtoDx | Commercial: COVID-19 Antibody Test | Device ID: 164 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: COVID-19 Antigen Cassetle Rapid Test (Pharyngeal swab) | Device ID: 2844 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit | Device ID: 1501 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit (Colloidal Gold) | Device ID: 2304 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit (Immunofluorescence Assay) | Device ID: 1187 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit - Nasal Swab (for Self-Test use) | Device ID: 2303 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: COVID-19 Antigen Mircrofluidic Chip | Device ID: 2820 | Method: Immunoassay | Target: Antigen | Format: Semi-automated | 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