| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Primerdesign Novacyt | Commercial: genesig(R) Coronavirus (COVID-19) Rt-PCR assay | Device ID: 1156 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Procomcure Biotech GmbH | Commercial: PhoenixDx SARS-Cov-2 IVD | Device ID: 971 | Method: RT-PCR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Progenie Molecular S.L.U. | Commercial: RealCycler CORO | Device ID: 322 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Promis Diagnostics | Commercial: SensDtect RT-qPCR SARS CoV-2 | Device ID: 323 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| 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: 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: 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: 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: 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: 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: 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: 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: Yes | Manufacturer: Redcell Biyoteknoloji | Commercial: Direct RT-qPCR SARS-CoV-2 | Device ID: 1714 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Redcliffebio | Commercial: LightPower iVASARS-CoV-2 1st RT-rPCR Kit | Device ID: 824 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: REFGEN BİYOTEKNOLOJİ ANONİM ŞİRKETİ | Commercial: RefKit SARS-CoV-2 Multiplex qPCR Assay | Device ID: 2926 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat System | Device ID: 2760 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: cobas SARS-CoV-2 (for use on the cobas 6800/8800 Systems) | Device ID: 339 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Device ID: 2761 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RTA | Commercial: SARS-CoV-2 Real Time PCR Kits | Device ID: 974 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Sacace BIOTECNOLOGIES | Commercial: SARS-CoV-2 Real-TM | Device ID: 487 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SACEM Hayat Teknolojileri A.S. | Commercial: iNADx Multiplex III COVID-19 RT-qPCR Kit | Device ID: 1836 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 342 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Schweitzer Biotech Company Ltd. | Commercial: SBC RNP qPCR Kit | Device ID: 799 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Schweitzer Biotech Company Ltd. | Commercial: SBC SARS-CoV-2 Convective PCR Diagnostic Device/Kit | Device ID: 801 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Schweitzer Biotech Company Ltd. | Commercial: SBC SARS-CoV-2 qPCR Kit | Device ID: 800 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: ScienCell Research Laboratories | Commercial: ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit | Device ID: 746 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Scope Fluidics SA | Commercial: PCR|COV | Device ID: 604 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD M nCoV Real-Time Detection Kit | Device ID: 343 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SEASUN BIOMATERIALS | Commercial: AQ-TOP COVID-9 Rapid Detection Kit | Device ID: 944 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SEASUN BIOMATERIALS | Commercial: U-TOP COVID-19 Detection Kit | Device ID: 347 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Seegene Inc. | Commercial: Allplex 2019-nCoV assay | Device ID: 348 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Seegene Inc. | Commercial: Allplex SARS-CoV-2 Assay | Device ID: 1128 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Selfdiagnostics Deutschland GmbH | Commercial: Multitest COVID-19 | Device ID: 4056 | Method: LAMP | Target: DNA, Nucleic acid, RNA | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sense Biodetection Limited | Commercial: Veros™ COVID-19 | Device ID: 3067 | Method: | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sente Biolab | Commercial: Senteligo Covid-19 qRT PCR Detection Kit | Device ID: 352 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SENTINEL CH. SpA | Commercial: STAT-NAT Covid-19 B | Device ID: 1436 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SENTINEL CH. SpA | Commercial: STAT-NAT Covid-19 HK | Device ID: 353 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SENTINEL CH. SpA | Commercial: STAT-NAT® SARS-CoV-2 - 1N044 | Device ID: 3031 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SENTINEL CH. SpA | Commercial: STAT-NAT® SARS-CoV-2 SN200 - 1N045S | Device ID: 2981 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: SENTINEL CH. SpA | Commercial: STAT-NAT® SARS-CoV-2 – 1N045 | Device ID: 3032 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shaanxi Lifegen Co. Ltd. | Commercial: Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method) | Device ID: 355 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shandong Shtars Biological Industry Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR Kit User Manual | Device ID: 356 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) | Device ID: 2019 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Conlight Medical Lab Co. Ltd. | Commercial: SARS-CoV-2/FluA/FluB/RSV detection kit（PCR MALDI-TOF-MS） | Device ID: 1821 | Method: Other | Target: Nucleic acid | Format: Lab-based | 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