| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: OACP S.R.L. | Commercial: Corona Virus Disease 2019 (CoViD-19) Nucleic Acid Detection Kit | Device ID: 967 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OPERON S.A. | Commercial: Real SARS-CoV-1/2 | Device ID: 1742 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: OPERON S.A. | Commercial: Real SARS-CoV-2 | Device ID: 1741 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OPERON S.A. | Commercial: Real SARS-CoV-2 PLUS | Device ID: 2980 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OPERON S.A. | Commercial: Real SARS-CoV-2/Flu/RSV | Device ID: 3145 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OPTI Medical Systems | Commercial: OPTI SARS-CoV-2 RT-PCR Test | Device ID: 1406 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: OPTOLANE Technologies Inc. | Commercial: Direct Dr. PCR™ SARS-CoV-2 Detection kit | Device ID: 1955 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: OPTOLANE Technologies Inc. | Commercial: Dr. PCR COVID-19 Viral Load 20K | Device ID: 303 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: OPTOLANE Technologies Inc. | Commercial: Dr. PCR™ Di20K COVID-19 Detection kit | Device ID: 1954 | Method: Digital-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OPTOLANE Technologies Inc. | Commercial: Kaira 2019-nCoV Detection kit | Device ID: 794 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Orig3n | Commercial: Orig3n 2019 Novel Coronavirus (COVID-19) Test | Device ID: 742 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder COVID-19 Fast RealAmp Kit | Device ID: 1591 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder COVID-19 RealAmp Kit | Device ID: 304 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: Simcere Novel Coronavirus (2019-NCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 860 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PathoFinder | Commercial: RealAccurate Quadruplex Corona-plus PCR Kit | Device ID: 591 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: PaxGen Bio Co. Ltd. | Commercial: Dr. PCR COVID-19 Viral Load 20K | Device ID: 306 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PaxGen Bio Co. Ltd. | Commercial: PaxView COVID-19 real time RT-PCR | Device ID: 866 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCLMD nCoV one step RT-PCR Kit | Device ID: 593 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: PCR BioSystems | Commercial: qPCRbio Probe 1-step-go Kit | Device ID: 887 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: PentaBase | Commercial: CoviDetect™ COVID-19 Multiplex RT-qPCR Assay | Device ID: 2915 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: PerkinElmer Inc. | Commercial: PerkinElmer New Coronavirus Nucleic Acid Detection Kit | Device ID: 743 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PerkinElmer Inc. | Commercial: PerkinElmer SARS-CoV-2 Realtime RT-PCR Assay | Device ID: 311 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pharmaline AS | Commercial: LAMPIGEN COVID19 RT-LAMP PCR KIT | Device ID: 1825 | Method: LAMP | Target: Nucleic acid | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Phosphorus Diagnostics | Commercial: COVID-19 RT-qPCR Test | Device ID: 1407 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pishtaz Teb Diagnostics | Commercial: COVID-19 One-Step COVID-19 RT-PCR Kit | Device ID: 595 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: PlexBio Co. Ltd. | Commercial: IntelliPlex SARS-CoV-2 Detection Kit | Device ID: 1408 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: PlexBio Co. Ltd. | Commercial: PlexBio CoVid19/SARS/Influenza A, B Detection kit | Device ID: 313 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Precision Biomonitoring Inc. | Commercial: TripleLock SARS-CoV-2 Test | Device ID: 2618 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: COVID-19 Lyophilised Nucleic Acid Kit | Device ID: 1075 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| 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: 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 |
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