| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Pharmaline AS | Commercial: RAPIDIGEN COVID19 AG IMMUNOASSAY | Method: Immunochromatography | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Hubei Jinjian Biology Co., Ltd | Commercial: SARS-CoV-2 Antigen Test Kit | Method: Immunochromatography | Target: Antigen | Format: Automated | 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: 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: 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: Beijing Savant Biotechnology Co., Ltd | Commercial: Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography) | Method: Immunochromatography | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Testsea Biotechnology Co., Ltd | Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod® SARS-CoV-2 IgG Test Kit | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod®616 IgG Test Kit | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genelogic Research Limited | Commercial: Genelogic COVID-19 IgM/IgG Antibody Test Kit | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV NAb | Method: Immunoassay | 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 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Rapid test 2019-nCoV Total Ig | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen GeneBioHealth Co., Ltd | Commercial: SARS-CoV- IgM IgG Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd | Commercial: SARS-CoV-2 IgG & IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc | Commercial: SARS-CoV-2 IgG/IgM Kit (manual) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Artron Laboratories Inc. | Commercial: Artron COVID-19 IgM/IgG Antibody Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NanoEntek | Commercial: FREND COVID-19 Ag | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC, Semi-automated | 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 Neutralizing Antibody Test Kit (colloidal gold method) | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: BIOSYNEX SWISS SA | Commercial: BIOSYNEX COVID-19 BSS | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: testsealabs | Commercial: COVID-19 IgG/IgM Antibody Test(Colloidal Gold) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 Neutralizing Antibody FIA | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Innova Medical Group, Inc. | Commercial: SARS-CoV-2 Antigen Rapid Qualitative Test | Method: Immunochromatography | Target: Antigen | Format: Lab-based | 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: SEASUN BIOMATERIALS | Commercial: AQ-TOP COVID-9 Rapid Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 IgG/IgM | Method: Immunoassay | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test Flu/COVID-19 Ag Combo | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: Biocard Covid-19 Rapid Test | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PZ CORMAY S.A. | Commercial: CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 Antigen Rapid Test Device | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Philosys Co., Ltd. | Commercial: Gmate® COVID-19 Ag Saliva | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: Ichroma COVID-19 Ab, IgM/IgG | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Immuno Biotech Co.,Ltd | Commercial: Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold) | Method: Immunoassay | Target: IgG | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co., Ltd | Commercial: SARS-COV-2/Influenza A&B Rapid Antigen Test | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Screen Italia SRL | Commercial: SCREEN TEST COVID-19 IgG/IgM - 2019-nCoV IgG/IgM Rapid Test Cassette | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Screen Italia SRL | Commercial: SCREEN TEST COVID-19 SALIVA | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PANION AND BF BIOTECH INC | Commercial: Vstrip COVID-19 Antigen Rapid Test | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech | Commercial: Coronavirus Ag Rapid Test Cassette (Swab) | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co., Ltd | Commercial: Covid-19 Antigen Rapid Test Kit | Method: Immunoassay | Target: Antigen | Format: Manual, 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: 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: AMS UK (NI) Ltd | Commercial: 2019-nCoV Antigen Device | Method: Immunochromatography | 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