| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: Foresight SARS-CoV-2 IgM | Method: Immunoassay | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: Foresight SARS-CoV-2 IgM EIA Test Kit | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Human anti-SARS-CoV-2 IgM ELISA | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-SARS-CoV-2 IgM | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgM antibody ELISA Test Kit | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: Microblot-Array COVID-19 IgM | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ansh Labs | Commercial: SARS-CoV IgM ELISA | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 IgM (CLIA) | Method: CLIA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pishtaz Teb Diagnostics | Commercial: SARS-CoV-2 IgM ELISA Kit | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ideal Tashkhis Atieh Co. | Commercial: SARS-CoV-2 IgM ELISA Kit | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AO Vector-Best | Commercial: SARS-CoV-2-IgM-EIA-BEST | Method: Immunoassay | Target: Antibody, IgM | Format: | Go to details |
| CE Marking: Yes | Manufacturer: InBios International | Commercial: SCoV-2 Detect IgM ELISA | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: VIROTECH Diagnostics GmbH | Commercial: VIROTECH SARS-CoV-2 IgM ELISA | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd | Commercial: Wantai SARS-CoV-2 IgM ELISA | Method: | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Wondof SARS-CoV-2 IgM Antibody Test | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vircell S.L. | Commercial: COVID-19 ELISA IgM+IgA | Method: ELISA | Target: Antibody, IgM, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vircell S.L. | Commercial: COVID-19 VIRCLIA IgM+IgA MONOTEST | Method: Immunoassay | Target: Antibody, IgM, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019- nCoV and Flu A/B Antigen Combo Rapid Test Kit (Colloid Gold Immunoassay) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019- nCoV Antigen Rapid Test | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Huachenyang (Shenzhen) Technology Co., Ltd. | Commercial: 2019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV Antigen Control (CGIA) | Method: Other | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV Antigen Control (CLIA) | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: 2019-nCoV Antigen Control (IFA) | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | 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 |
| 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: Beijing Lepu Medical Technology Co., Ltd | Commercial: 2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Method: Immunochromatography | Target: Antigen | Format: Other | 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: 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: Edinburgh Genetics Limited | Commercial: ActivXpress+ COVID-19 Antigen Complete Testing Kit | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: AFIAS COVID-19, Viral Antigen | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: AFIAS COVID-19, Viral Antigen (automated) | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: AFIAS COVID-19/Flu Ag Combo | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Amedica SA | Commercial: Amela Covid-19 Antigen test | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 Ag | 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 | Method: Immunoassay | Target: Antigen | 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) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd. | Commercial: AndLucky SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non-invasive) | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Lifotronic Technology Co, Ltd | Commercial: Antigen Rapid Test Ag SARS-CoV-2 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: A. Menarini Diagnostics | Commercial: ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co., Ltd | Commercial: Antigen Rapid Test COVID-19 Coretests | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: Aria COVID-19 Ag Rapid Test | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ARISTA Biotech Pte. Ltd | Commercial: ARISTA COVID-19 Antigen Rapid Test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 Ag | Method: | Target: Antigen | Format: Near POC / POC | 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: biocomma limited | Commercial: biocomma®COVID-19 Antigen Test Kit | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioVendor; RapiGEN Inc | Commercial: BIOCREDIT COVID-19 Ag | 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