CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Molbio Diagnostics Private Limited | Commercial: Truenat® COVID-19 | Device ID: 2913 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Molbio Diagnostics Private Limited | Commercial: Truenat® SARS CoV-2 | Device ID: 286 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Molgentix S.L. | Commercial: CoviNplex™ One Step RT-PCR Kit For qualitative detection of SARS-CoV-2 assay | Device ID: 2176 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Monocent Inc. | Commercial: SARS-CoV2 RT-PCR | Device ID: 1330 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: RapidScript SARS-CoV-2 Assay | Device ID: 1127 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19 qPCR Allplex | Device ID: 2027 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTest COVID-19 qPCR ALLPLEX Kit | Device ID: 1692 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTest COVID-19 qPCR MULTIPLEX | Device ID: 1315 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19 qPCR Rapid Kit | Device ID: 2859 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19 qPCR SuperRapid Kit | Device ID: 3156 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19/FLU qPCR DIAGNOSTIC KIT | Device ID: 1332 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: vDetect COVID-19 RT-qPCR diagnostic kit | Device ID: 1077 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: COMPACT MINI/DX/XLDX- Nucleic Acid Amplification (PCR) Analyzer | Device ID: 2359 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: COMPACT X/COMPACT XL- Nucleic Acid Sample Extraction and Preparation Instrument | Device ID: 2344 | Method: RT-PCR | Target: | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Magnetic Bead Based-Compatible with COMPACTX/XL) | Device ID: 2356 | Method: RT-PCR | Target: Nucleic acid | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: Maverick- Nucleic Acid Extraction Kit (Spin Column Based) | Device ID: 2347 | Method: RT-PCR | Target: | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Ag Qualitative PCR Kit | Device ID: 2358 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Ag Qualitative PCR Kit (Compatible with the Automated Extraction System- COMPACT X/XL) | Device ID: 2357 | Method: RT-PCR | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Qualitative PCR Kit | Device ID: 288 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Qualitative PCR Kit (Compatible with the Automated Extraction System- COMPACT X/XL) | Device ID: 2406 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: ViroTrap- Molecular Transport Medium | Device ID: 2346 | Method: RT-PCR | Target: | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: ViroTrap- Viral Transport Medium | Device ID: 2345 | Method: RT-PCR | Target: | Format: Manual | Go to details |
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: 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: 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: 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: 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 IE Ltd. | Commercial: Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit | Device ID: 2442 | Method: RT-PCR | Target: | Format: Automated, Manual, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: OACP IE Ltd. | Commercial: Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR Method) | Device ID: 2443 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | 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: Omixon Biocomputing Kft. | Commercial: AzureSeq CE qPCR Kit SARS-CoV-2 for 200 Reactions | Device ID: 2363 | 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: 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: 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: 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 |
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