| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai International Holding Corp. GmbH(Europe) (DE) | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biozek - Inzek International Trading | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACRO Biotech | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Syrona Limited | Commercial: COVID-19 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: COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOLAN HEALTH, S.L. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 IgG/IgM Rapid Test (Strip) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 IgG/IgM Rapid Test (For Reader) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 IgG/IgM Rapid Test (For Reader) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spring Healthcare Services AG | Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 IgG/IgM Rapid Test (cassette) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech | Commercial: COVID-19 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biozek | Commercial: Covid-19 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zenum Technologies | Commercial: COVID-19 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Monocent, Inc | Commercial: COVID-19 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Lituo Biotechnology Co., Ltd | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Liming Bio-Products Co., Ltd | Commercial: COVID-19 IgG/IgM Combo Rapid Test Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: NTBio Diagnostics Inc | Commercial: COVID-19 IgG/IgM Antibody Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan UNscience Biotechnology Co., Ltd | Commercial: Covid-19 IgG/IgM Antibody Rapid Test Kit | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 IgG/IgM Antibody Assay Kit(Colloidal Gold Method) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: COVID-19 IgG Rapid Test (strip) | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: COVID-19 IgG Rapid Test (cassette) | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 IgG Rapid Test | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 IgG Rapid Test | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: COVID-19 IgG IgM Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Monocent, Inc | Commercial: COVID-19 IgG ELISA | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: COVID-19 IgG Antibody Test Kit (colloidal gold method) | Method: Immunoassay | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Monocent, Inc | Commercial: COVID-19 IgA ELISA | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | 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 ELISA IgG | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic PCR Solutions | Commercial: CoVID-19 dtec-RT-qPCR Test | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic PCR solutions; Genetic Analysis Strategies S.L. | Commercial: CoVID-19 dtec-RT-qPCR Test | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bioperfectus Technologies Co. Ltd (Jiangsu) | Commercial: COVID-19 Coronavirus Real Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Newbury Pharmaceuticals S.A | Commercial: COVID-19 Coronavirus Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AssayGenie | Commercial: COVID-19 CE IVD qPCR assay | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan NanoDiagnosis for Health Biotechnology Co., Ltd | Commercial: COVID-19 Antigen/FLU A+B Antigen Combo Rapid Test Cassette (Colloidal Gold Method) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Nano Diagnosis of Health Biotechnology Co., Limited | Commercial: COVID-19 Antigen/Flu A+B Antigen Combo Rapid Test Cassette | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AmonMed Biotechnology Co., Ltd | Commercial: COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lansion Biotechnology Co., Ltd. | Commercial: COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology | Commercial: COVID-19 Antigen Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACRO BIOTECH, Inc. | Commercial: COVID-19 Antigen Test Cassette (For Analyzer) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: COVID-19 Antigen Test cassette (FIA) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HANGZHOU TESTSEA BIOTECHNOLOGY CO.,LID . | Commercial: COVID-19 Antigen Test Cassette | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 Antigen Test Cassette | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ultimed Products (Deutschland) GmbH | Commercial: COVID-19 Antigen Test (Nasopharyngeal Swab) | 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