| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: H&Z Life Science Co. Ltd | Commercial: Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay) | Device ID: 1172 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tianjin MNCHIP Technologies Co., Ltd | Commercial: Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay) | Device ID: 404 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: AndLucky SARS-CoV-2 Antigen Anterior Nasal Rapid Test (minimal invasive) | Device ID: 1842 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: AndLucky COVID-19 Antigen Rapid Test | Device ID: 1296 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 IgG/IgM | Device ID: 993 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 Ag | Device ID: 1304 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag | Device ID: 1647 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sanwa Biotech Limited | Commercial: ALiA SARS-CoV-2 Antigen FIA Test | Device ID: 2115 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AESKU.DIAGNOSTICS GmbH & Co. KG | Commercial: AESKU.RAPID SARS-CoV-2 | Device ID: 2108 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: ActivXpress+ COVID-19 Antigen Complete Testing Kit | Device ID: 1243 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AIDIAN | Commercial: Acro 2019-nCoV IgG/IgM pikatesti | Device ID: 994 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: ACON SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 1675 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd | Commercial: Accu-Tell COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 14 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co., Ltd | Commercial: Absoludy COVID-19 IgM/IgG Rapid | Device ID: 1151 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AB Dianostic Systems GmbH | Commercial: abia SARS-CoV- IgG/IgM | Device ID: 913 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abingdon Health Plc | Commercial: AbC-19 Rapid Test | Device ID: 1992 | Method: Immunoassay | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: Abbott ID NOW COVID-19 | Device ID: 496 | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: A&B Professional | Commercial: A&B RAPID TEST COVID-19 IGG/IGM CASSETTA | Device ID: 1004 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD | Commercial: A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2-(ICA) | Device ID: 1645 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD | Commercial: A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2 (ICA) | Device ID: 1680 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tregena | Commercial: 3gamma COVID-19 IgA / IgM / IgG | Device ID: 1026 | Method: Immunoassay | Target: Antibody, IgG, IgM, IgA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Akralab | Commercial: 2019nCoV IgG/IgM Rapid test Device | Device ID: 1002 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV/IAV/IBV Antigen Test Kit (colloidal gold method) | Device ID: 1809 | Method: Immunoassay | Target: Antigen | 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: 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: Neo Nostics (Suzhou) Bioingeneering Co. LTD | Commercial: 2019-nCoV(COVID-19) IgG&IgM Rapid Test Kit | Device ID: 1022 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: 2019-nCoV Saliva Ag EASY TEST | Device ID: 2498 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co., LTD | Commercial: 2019-nCoV Rapid Antigen Test | Device ID: 2468 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay) | Device ID: 1879 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: 2019-nCoV Neutralizing Antibody Assay (Colloidal Gold) | Device ID: 2220 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co.,Ltd | Commercial: 2019-nCoV IgMIgG Antibody Test Kit POCT Immunoassay System - HP-083/4 | Device ID: 1094 | Method: Nephelometry | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co.,Ltd | Commercial: 2019-nCoV IgMIgG Antibody Test Kit (Nephelometry immunoassay method) Automatic ImmunoAssay System - HP-AFS/1 | Device ID: 1095 | Method: Nephelometry | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method) | Device ID: 1807 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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, IgM | Format: Near POC / POC | 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: U2USystems (India) Pvt. Ltd | Commercial: 2019-ncoV IgG/IgM Test | Device ID: 489 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: 2019-nCoV IgG/IgM Rapid Testing Kit | Device ID: 766 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2434 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2438 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOMAXIMA S.A. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 88 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 208 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 1390 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 1696 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 568 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 1070 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd | Commercial: 2019-nCoV IgG/IgM Device | Device ID: 1048 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biolidics | Commercial: 2019-nCoV IgG/IgM Antibody Detection Kit | Device ID: 497 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen AmonMed Biotechnology Co., Ltd | Commercial: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | Device ID: 959 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) | Device ID: 1747 | Method: Immunoassay | 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