| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Verify Diagnostics Inc | Commercial: Covid-19 IgG/IgM Antibody Test | Device ID: 628 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Veredus Laboratories Pte Ltd | Commercial: VereCoV OneMix Detection Kit for VerePLEX Biosystem | Device ID: 419 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Vela Diagnostics | Commercial: ViroKey SARS-CoV-2 RT-PCR Test | Device ID: 751 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Vela Diagnostics | Commercial: SARS-CoV-2 Direct Test | Device ID: 193 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Vela Diagnostics | Commercial: Great Basin System SARS-CoV-2 Direct Test | Device ID: 813 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: VEDALAB | Commercial: COVID-19-CHECK-1 test | Device ID: 1069 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VEDALAB | Commercial: COVID-19-CHECK-1 Antigen | Device ID: 1956 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vector-Best | Commercial: SARS-CoV-2-IgM-EIA-BEST | Device ID: 1464 | Method: Immunoassay | Target: Antibody, IgM | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vector-Best | Commercial: SARS-CoV-2-IgG-EIA-BEST | Device ID: 1463 | Method: Immunoassay | Target: Antibody, IgG | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Vector-Best | Commercial: RealBest RNA SARS-CoV-2 | Device ID: 1462 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) | Device ID: 28 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: 2019-nCoV IgG/IgM Rapid Testing Kit | Device ID: 766 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vatic Health Ltd. | Commercial: KnowNow SARS-CoV-2 Rapid Antigen Test | Device ID: 2508 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Van Oostveen Medical B.V. | Commercial: Coronavirus Ag Rapid Test Cassette (Swab) | Device ID: 1831 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vacure Prelab Medical Technology Co., Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit (Immunochromatography) | Device ID: 2041 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd | Commercial: EasyNAT Integrated, Automated Molecular Diagnostic Assay for COVID-19 RNA | Device ID: 418 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay) | Device ID: 1879 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd | Commercial: 2019- nCoV Antigen Rapid Test | Device ID: 1873 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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) | Device ID: 1874 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnoligies | Commercial: Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal AmplificationReal Time Fluorescence Assay) | Device ID: 2600 | Method: Other | Target: Nucleic acid | Format: Near POC / POC, Other | Go to details |
| CE Marking: No | Manufacturer: UPMC | Commercial: COVID-19 test | Device ID: 416 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: University of Washington | Commercial: Tongue swab diagnosis of SARS-CoV-2 | Device ID: 415 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: University of North Carolina Medical Center McLendon Clinical Laboratories | Commercial: COVID-19 PCR, on WHO protocol | Device ID: 414 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: University of Hong Kong | Commercial: Two single-step quantitative RT reverse transcription PCR assays for N gene and ORF1b of sarbecovirus subgenus | Device ID: 413 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: United Biomedical | Commercial: UBI SARS-CoV-2 ELISA | Device ID: 698 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Unioninvest Ltd. | Commercial: Unibioscience Covid-19 Nasopharynx Antigen Test | Device ID: 2523 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unioninvest Ltd. | Commercial: COVID-19 ANTIGEN RAPID TEST NASAL | Device ID: 2249 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Unimed International, Inc. | Commercial: OnSight™- COVID-19 NAb Quantitative Test | Device ID: 2135 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unimed International, Inc. | Commercial: OnSight™ - COVID-19 IgG/IgM Combo Test | Device ID: 2133 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unimed International, Inc. | Commercial: OnSight™ - COVID-19 Antigen Test | Device ID: 2131 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Vaxxitest 2019-nCoV Neutralizing Antibody Test | Device ID: 2521 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Unibioscience Covid-19 Rapid Antigen Saliva Test | Device ID: 2522 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ulti Med Products GmbH | Commercial: COVID-19 Antigen Test (Nasopharyngeal Swab) | Device ID: 1455 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ulti Med Products GmbH | Commercial: COVID-19 Antigen test | Device ID: 1378 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ulti Med Products GmbH | Commercial: COVID-19 Antigen Saliva Test (Immunochromatography) | Device ID: 1641 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ulti Med Products GmbH | Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) | Device ID: 1391 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ukrgentech | Commercial: RT-PCR test kit for COVID-9 detection | Device ID: 952 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: UAB Imunodiagnostika | Commercial: SARS-CoV-2 S IgG ELISA | Device ID: 1740 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: U2USystems (India) Pvt. Ltd | Commercial: 2019-ncoV IgG/IgM Test | Device ID: 489 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Twist Bioscience | Commercial: NGS-based target capture for SARS-CoV-2 detection and screening | Device ID: 412 | Method: Sequencing | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: INFO Covid-19 Ag Test | Device ID: 2584 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Turklab | Commercial: Toyo SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1723 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Turklab | Commercial: TOYO Covid-19 Ag Test | Device ID: 1722 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Turklab | Commercial: SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1690 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Turklab | Commercial: RAPIDAN TESTER SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1752 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Turklab | Commercial: RAPIDAN TESTER Covid-19 Ag Test | Device ID: 1751 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Turklab | Commercial: INFO SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1753 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Turklab | Commercial: Covid-19 Ag Test | Device ID: 1689 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: ViSure transport kit | Device ID: 816 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd | Commercial: RNAsure RNA Extraction Kit | Device ID: 951 | Method: Other | Target: Nucleic acid | Format: Manual | 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