| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: biocomma limited | Commercial: biocomma®COVID-19 Antigen Test Kit | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PZ CORMAY S.A. | Commercial: Cormay Rapid SARS-CoV-2 IgG/IgM Ab | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co., Ltd | Commercial: COVID-19 Antigen Detection Kit | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VEDALAB | Commercial: COVID-19-CHECK-1 test | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEXACARE GmbH | Commercial: MEXACARE COVID-19 Antigen Rapid Test | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL COVID-19 Ag Test | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 IgG/IgM Antibody Assay Kit by Immunofluorescence Chromatography Method | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Nano Diagnosis of Health Biotechnology Co., Limited | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette ( Colloidal Gold Method) | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology | Commercial: (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Natejah | Commercial: (COVID-19) IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JinHuan Medical Instrument Co., Ltd | Commercial: (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lansion Biotechnology Co., Ltd. | Commercial: (COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: 2019 nCOV IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: 2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co., Ltd (CN); Sungo Europe B. V. (NL) | Commercial: 2019-nCoV Ab Test (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovita Biological Technology | Commercial: 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK | Commercial: 2019-nCoV Antigen Device | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co., Ltd | Commercial: 2019-nCoV Antigen Rapid Test (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd | Commercial: 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing M&D Biotechnology Co. Ltd. | Commercial: 2019-nCoV Antigen Test Kit | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AmonMed Biotechnology Co., Ltd | Commercial: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | 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 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biolidics | Commercial: 2019-nCoV IgG/IgM Antibody Detection Kit | 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 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd | Commercial: 2019-nCoV IgG/IgM Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOMAXIMA S.A. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | 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 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: 2019-nCoV IgG/IgM Rapid Testing Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: U2USystems (India) Pvt. Ltd | Commercial: 2019-ncoV IgG/IgM Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: 2019-nCOV IgG/LgM Rapid Test Device | 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 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd | Commercial: 2019-nCoV IgM Antibody Diagnostic Kit (Colloidal gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) CO., LTD | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Neo Nostics (Suzhou) Bioingeneering Co. LTD | Commercial: 2019-nCoV(COVID-19) IgG&IgM Rapid Test Kit | Method: Immunoassay | Target: Antibody | 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) | Method: Immunoassay | Target: Antigen | 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) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Akralab | Commercial: 2019nCoV IgG/IgM Rapid test Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tregena | Commercial: 3gamma COVID-19 IgA / IgM / IgG | Method: Immunoassay | Target: Antibody, IgG, IgM, IgA | 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) | 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) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co., Ltd | Commercial: Absoludy COVID-19 IgM/IgG Rapid | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd | Commercial: Accu-Tell COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: 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 | Method: Immunoassay | Target: IgG, IgM | 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