| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Nanjing Liming BioProducts Co. Ltd. | Commercial: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) | Device ID: 1224 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit | Device ID: 291 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: NanoBio Lab A*STAR Research Entities | Commercial: Isothermal Exponential Amplification for COVID-19 Detection | Device ID: 292 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Nationwide Children's Hospital | Commercial: SARS-CoV-2 Assay | Device ID: 739 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Navid | Commercial: COVID-19 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method) | Device ID: 326 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: NeuMoDx Molecular | Commercial: NeuMoDx SARS-CoV-2 Assay | Device ID: 740 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Next Pharma Inc. | Commercial: DiaCarta's QuantiVirusTMSARS-CoV-2 Test | Device ID: 295 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Ningbo Health Gene Technologies Co. Ltd. | Commercial: SARS-CoV-2 Virus Detection Diagnostic Kit (RT- qPCR Method) | Device ID: 296 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Norgen Biotek Corp. | Commercial: 2019-nCoV TaqMan RT-PCR Kit (Catalog# TM67100) | Device ID: 298 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: 2019-nCoV TaqMan RT-PCR Kit Dx (DxTM67100) | Device ID: 1158 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: COVID19 TaqMan RT-PCR Kit Dx (E-RdRP genes) (DxTM67200) | Device ID: 1160 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: NorthShore University HealthSystem | Commercial: Novel Coronavirus test | Device ID: 299 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Northwell Health | Commercial: 2019 Novel Coronavirus PCR | Device ID: 300 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaPrime SARS-CoV- (COVID-19) | Device ID: 940 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaPrime® Plus SARS-CoV-2 | Device ID: 2321 | Method: RT-PCR | Target: | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaType II SARS-CoV-2 | Device ID: 2322 | Method: RT-PCR | Target: | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Nuclear Laser Medicine srl | Commercial: SArs-CoV-2 Real Time | Device ID: 2296 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: NY State Department of Health | Commercial: New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel | Device ID: 302 | Method: RT-PCR | Target: IgA, IgG, IgM, Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: NZYTech | Commercial: SARS-CoV-2 One-Step RT-PCR Kit | Device ID: 1927 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| 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: No | Manufacturer: Paragon Genomics Inc. | Commercial: CleanPlex SARS-CoV-2 Research and Surveillance NGS Panel | Device ID: 305 | Method: Other | Target: Nucleic acid | Format: Near POC / POC | 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: Yes | Manufacturer: PharmaNona | Commercial: FOAMING TEST | Device ID: 1447 | Method: Other | Target: Nucleic acid | Format: 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 |
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