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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

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471 records found
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