| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: QIAGEN GmbH | Commercial: QIAstat-Dx Respiratory Panel 2019-nCoV | Device ID: 324 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Funuo Biomedical Co. Ltd. | Commercial: COVID-19 Multiplex Fluorescent PCR Kit | Device ID: 598 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: COVIDTECH One Step SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 1452 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: Hightop COVID-19 IgM/IgG Ab Rapid Test Kit | Device ID: 325 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 463 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 1341 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Immunochromatography) | Device ID: 2191 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-COV-2 IGM/IGG ANTIBODY RAPID TEST | Device ID: 1340 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test | Device ID: 2754 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Quansys Biosciences | Commercial: Human COVID-19 (2-plex) | Device ID: 327 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: QuantuMDx Group Ltd. | Commercial: Q-POC | Device ID: 2646 | Method: RT-PCR | Target: | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: QuantuMDx Group Ltd. | Commercial: QPOC Point of Care NAT for SARS-CoV-2 | Device ID: 329 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: QuantuMDx Group Ltd. | Commercial: QuantuMDx NAT for SARS-CoV-2 | Device ID: 328 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Quest Diagnostics | Commercial: Coronavirus Disease 2019 (COVID-19) Test | Device ID: 330 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: Lyra SARS-CoV-2 Assay | Device ID: 331 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: QuickVue SARS Antigen FIA | Device ID: 2269 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: Savanna RVP-4 panel assay | Device ID: 2903 | Method: RT-PCR | Target: Nucleic acid | Format: Fully automated (robot), Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: Sofia Flu + SARS Antigen FIA | Device ID: 2682 | Method: Immunoassay | Target: Antigen | Format: Automated, Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: Sofia SARS Antigen FIA | Device ID: 1097 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: Solana SARS CoV-2 Assay | Device ID: 2855 | Method: Other | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: QuikPath Pte Ltd. | Commercial: QuikPath Covid-19 POC molecular test | Device ID: 599 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Quotient Limited SA | Commercial: MosaiQ COVID-19 Antibody Microarray | Device ID: 600 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: R-Biopharm AG | Commercial: RIDA®@QUICK SARS-CoV-2 Antigen | Device ID: 1846 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: R-Biopharm AG | Commercial: RIDA®GENE Flu & SARS-CoV-2 | Device ID: 1851 | Method: RT-PCR | Target: Nucleic acid | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: R-Biopharm AG | Commercial: RIDA®GENE SARS-CoV-2 | Device ID: 332 | Method: RT-PCR | Target: Nucleic acid | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: R-Biopharm AG | Commercial: RIDA®QUICK SARS-CoV-2 Antigen | Device ID: 2214 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: RainSure Scientific Co. Ltd. | Commercial: RainSure COVID-19 dPCR Detection Kit (lab-based) | Device ID: 333 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: RAM THz Solutions GmbH | Commercial: ThEA DSS-F1 | Device ID: 3120 | Method: Other | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Randox Laboratories Ltd. | Commercial: Extended Coronavirus Array | Device ID: 334 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Rapid Bio LLC | Commercial: Rapid test for IgM/IgG antibodies against SARS-COV-2 | Device ID: 601 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Rapid Diagnostic Systems Limited | Commercial: NaorCov19 | Device ID: 2548 | Method: LAMP | Target: | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Rapid Labs Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 5812 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Rapid Labs Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal Swab) | Device ID: 3096 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Rapid Pathogen Screening Inc. | Commercial: LIAISON® Quick Detect Covid Ag Assay | Device ID: 2290 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 Ag | Device ID: 1962 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 Ag - SARS-CoV 2 Antigen test | Device ID: 1606 | Method: Immunoassay | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 Ag Test Nasal | Device ID: 1963 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 IgG | Device ID: 602 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 IgG+IgM Duo | Device ID: 336 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 IgG/IgM Combo | Device ID: 1716 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: RapiGEN Inc. | Device ID: 1832 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: RayBiotech | Commercial: Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) | Device ID: 337 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RDSM nv | Commercial: COVID-19 Antigen test | Device ID: 1238 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Reach Diagnostic (Wuhan) Biotech Co. Ltd. | Commercial: 2019-nCoV Ag & FLU A/B ComboRapid Test | Device ID: 4086 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Reach Diagnostic (Wuhan) Biotech Co. Ltd. | Commercial: SARS-COV-2 Ag Rapid Test | Device ID: 2954 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Reach Diagnostic (Wuhan) Biotech Co. Ltd. | Commercial: SARS-COV-2 Ag Rapid Test Cassette | Device ID: 3154 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Reagens Ltd. | Commercial: Cov2Quant™ SARS-CoV-2 Quantification Kit | Device ID: 2367 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Reagens Ltd. | Commercial: Inf-Cov2Quant™ Influenza A/B + SARS-CoV-2 Quantification Kit | Device ID: 2372 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Realy Tech | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2298 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Red Cell Biyoteknoloji A.Ş. | Commercial: Red Cell COVID-19 Self Test | Device ID: 3972 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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