| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Xi'an Goldmag Nanobio Tech Co., Ltd | Commercial: Real-Time RT-PCR assays for the detection of SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BGI | Commercial: Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Suzhou BTA Biotech Co. Ltd | Commercial: Real time RT-PCR Kit for the detection of SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Landcent Europe B.V. | Commercial: Real time RT-PCR Kit for the detection of SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biotech & Biomedicine (Shenyang) Group Ltd | Commercial: Real Time PCR Detection Kit For COVID-19 Coronavirus | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OPERON, S.A. | Commercial: Real SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OPERON, S.A. | Commercial: Real SARS-CoV-1/2 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Rapigen Inc. | Commercial: RapiGEN Inc. | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Weifang Kanghua Biotech | Commercial: RAPIDTECH Test Rapide Antigène SARS-CoV-2 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: RapidScript SARS-CoV-2 Assay | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pharmaline AS | Commercial: RAPIDIGEN COVID19 AG IMMUNOASSAY | Method: Immunochromatography | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biyoteknoloji Ltd. Şti. | Commercial: RapidFor SARS-CoV-2 Rapid Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co., Ltd. | Commercial: RapidFor SARS-CoV-2 IgG/IgM Test Kit | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co., Ltd | Commercial: RapidFor SARS-CoV-2 Antigen Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: RAPIDAN TESTER SARS-CoV-2 IgM/IgG Ab Test | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: RAPIDAN TESTER Covid-19 Ag Test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Technogenetics SRL | Commercial: RAPID TEST SARS-CoV-2 IgM/IgG GOLD | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMP Diagnostics (AMEDA Labordiagnostik GmbH) | Commercial: Rapid Test SARS-CoV-2 Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Dabo Pharmaceutical Co., Ltd | Commercial: Rapid test for IgM/IgG Antibody to SARS-CoV-2 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Rapid Bio LLC | Commercial: Rapid test for IgM/IgG antibodies against SARS-COV-2 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhezhiang Orient Gene Biotech Co Ltd | Commercial: RAPID TEST AntigenE GCCOV-502a | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Liming Bio | Commercial: Rapid Test Antigen SARS- CoV-2 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Rapid Test Ag 2019-nCov | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: Immunospark s.r.l. | Commercial: Rapid SARS-Cov2 Antigen Test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals Germany GmbH | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec PRODUCTS, INC. | Commercial: Rapid SARS-CoV-2 Antigen Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products, Inc | Commercial: Rapid SARS-CoV-2 Antibody Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products, Inc | Commercial: Rapid SARS-CoV-2 Antibody (IgM/IgG) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BTNX Inc | Commercial: Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX | Commercial: Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc | Commercial: Rapid Response COVID-19 Antigen Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid New Coronavirus (COVID19) Neutralizing Antibody Test | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid New Coronavirus (COVID19) IgG/IgM Combo Test | Method: Immunochromatography | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: Rapid Immunoassay Test Cassette | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sherlock Biosciences | Commercial: Rapid CRISPR-based tests for SARS-CoV-2 and other pathogens | Method: CRISPR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc | Commercial: Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd. | Commercial: Rapid COVID-19 Antigen Test(Colloidal Gold) | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Healgen Scientific Limited Liability Company | Commercial: Rapid COVID-19 Antigen Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Healgen | Commercial: Rapid COVID-19 Antigen Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc | Commercial: Rapid COVID-19 Antigen Qualitative Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech, Inc | Commercial: Rapid COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd | Commercial: Rapid 2019-nCoV IgG/IgM Combo Test Card | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Rapid 2019-nCoV IgG/IgM Combo Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: RainSure Scientific Co., Ltd | Commercial: RainSure COVID-19 dPCR Detection Kit (lab-based) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: KH Medical Co. Ltd | Commercial: RADI COVID-19 Detection Kit and RADI COVID-19 Triple Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Abwiz Bio | Commercial: RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA) | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: QuikPath Pte Ltd | Commercial: QuikPath Covid-19 POC molecular test | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Tianjin New Bay Bioresearch C | Commercial: Quik Pac II COVID-19 IgG & IgM Test | Method: Immunoassay | Target: Antibody, 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