| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: 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: 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: 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 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 Test (Nasopharyngeal Swab) | Device ID: 1455 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Unibioscience Covid-19 Nasopharynx Antigen Test | Device ID: 2523 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Unibioscience Covid-19 Rapid Antigen Saliva Test | Device ID: 2522 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Unibioscience® COVID-19 Ag Home Test | Device ID: 2826 | Method: Immunoassay | Target: Antigen | Format: Manual, 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: 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: 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 NAb Quantitative Test | Device ID: 2135 | Method: Immunochromatography | Target: IgG | Format: 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: 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: 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 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 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: EasyNAT COVID-19 RNA Test | Device ID: 3135 | Method: Other | Target: Nucleic acid | Format: Manual | 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: 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: 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: 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: 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: 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: 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: 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: SARS-CoV-2-IgM-EIA-BEST | Device ID: 1464 | Method: Immunoassay | Target: Antibody, IgM | Format: | 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: COVID19-CHECK1 ANTIGEN | Device ID: 1956 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: 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: Vicare Solution GmbH | Commercial: Vicare Rapid FL | Device ID: 2930 | Method: LAMP | Target: Nucleic acid | Format: Lab-based, Manual, Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: Rapid-VIDITEST anti- SARS-CoV-2 (RBD) IgG | Device ID: 2334 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: Rapid-VIDITEST anti- SARS-CoV-2 IgG/IgM | Device ID: 2336 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: Rapid-VIDITEST SARS-CoV-2 Antigen | Device ID: 2073 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VIDIA spol. s r.o. | Commercial: SARS-CoV-2 Antigen | Device ID: 2061 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ViennaLab Diagnostics GmbH | Commercial: SARS-CoV-2 RealFast™ Assay | Device ID: 2530 | Method: RT-PCR | Target: | Format: Automated, Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: VIMEK BIOCONCEPT PVT Ltd. | Commercial: Covid-19 Antigen test | Device ID: 2998 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: VIMEK BIOCONCEPT PVT Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test | Device ID: 3000 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Viola Diagnostics Systems-Tulip Diagnostics | Commercial: PerkinElmer® COVID-19 Antigen Test | Device ID: 3147 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: AMPLIRUN SARS-CoV-2 RNA CONTROL | Device ID: 629 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: AMPLIRUN TOTAL SARS-CoV-2 CONTROL (SWAB) | Device ID: 491 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: AMPLIRUN® TOTAL SARS-CoV-2/FluA/FluB/RSV CONTROL (SWAB) | Device ID: 4144 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: COVID-19 SPIKE QUANTITATIVE VIRCLIA® IgG MONOTEST | Device ID: 2081 | Method: Immunoassay | Target: Antibody, IgG | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: COVID-19 VIRCLIA IgG MONOTEST | Device ID: 422 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: COVID-19 VIRCLIA IgM+IgA MONOTEST | Device ID: 424 | Method: Immunoassay | Target: Antibody, IgA, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: DIRECT SARS-COV-2 REALTIME PCR KIT | Device ID: 2082 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: SARS-COV-2 OMICRON REALTIME PCR KIT | Device ID: 4136 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: SARS-COV-2 PLUS UK REALTIME PCR KIT | Device ID: 4134 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Automated | 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