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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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668 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: No Manufacturer: GenoSensor Commercial: GS COVID-19 RT-PCR Kit Device ID: 723 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Genrui Biotech Inc. Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) Device ID: 1925 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: GenScript Commercial: 2019-nCoV qRT-PCR Detection Assay Device ID: 188 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: gerbion GmbH & Co. Commercial: KG virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 Device ID: 567 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Getein Biotech Inc. Commercial: Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit Device ID: 189 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Getein Biotech Inc. Commercial: Novel Coronavirus Real Time PCR Kit Device ID: 892 Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: No Manufacturer: GFE Commercial: SARS-CoV-2 PCR Reagent Kit Device ID: 822 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: GNA Biosolutions GmbH Commercial: Sars-CoV-2 Detection Kit on portable PCA Analyzer Device ID: 191 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Gnomegen Commercial: Gnomegen COVID-19 RT-Digital PCR Detection Kit Device ID: 724 Method: Digital-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Goldsite Diagnostics Inc. Commercial: SARS-CoV-2 Real-time RT-PCR Kit Device ID: 1666 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Green Cross Medical Science Corp. Commercial: GENEDIA W COVID-19 Colorimetric LAMP premix kit Device ID: 1143 Method: LAMP Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Green Cross Medical Science Corp. Commercial: GENEDIA W COVID-19 Real Time RT-PCR kit Device ID: 1142 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Guangdong Hecin Scientific Inc. Commercial: 2019-nCoV Nucleic Acid Test Kit (PCR- fluorescence probe method) Device ID: 1805 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Guangdong Hecin Scientific Inc. Commercial: 2019-nCoV/IAV/IBV Nucleic Acid Test Kit (PCR- fluorescence probe method) Device ID: 1808 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Guangdong Hecin Scientific Inc. Commercial: HC800 Device ID: 2863 Method: RT-PCR Target: Nucleic acid Format: Lab-based, Manual, Near POC / POC, Semi-automated Go to details
CE Marking: Yes Manufacturer: Guangdong Hecin Scientific Inc. Commercial: UltraFast QPCR HC1600 Device ID: 4095 Method: RT-PCR Target: Nucleic acid Format: Lab-based, Manual, Near POC / POC, Semi-automated Go to details
CE Marking: No Manufacturer: Guangdong Huayin Medicine Science Co. Ltd. Commercial: Detection Kit for 2019-nCoV RNA (RT-PCR Fluorescence Probing) (Lyophilised) Device ID: 194 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Guangdong Longsee Biomedical Co. Ltd. Commercial: 2019-nCoV Nucleic Acid Detection Kit (Q-PCR Method) Device ID: 1057 Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Guangdong Longsee Biomedical Co. Ltd. Commercial: 2019-nCoV Nucleic Acid Detection Kit (RT-IMSA Method) Device ID: 1217 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Guangzhou Biokey Health Technologies Co. Ltd. Commercial: Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit Device ID: 3069 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Guangzhou Biokey Health Technologies Co. Ltd. Commercial: Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit (Lyophilized) Device ID: 3070 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Guangzhou FulenGen Co. Ltd. Commercial: RT-qPCR based SARS-CoV-2 detection kit with SPRS (Spike-in Reference Standard) Device ID: 200 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Guangzhou HEAS BioTech Co. Ltd. Commercial: 2019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method) Device ID: 201 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Guangzhou Hybribio Medicine Technology Ltd. Commercial: Respiratory Virus (IFVa/b + COVID-19) Real-Time PCR Kit Device ID: 202 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Guangzhou Pluslife Biotech Co. Ltd. Commercial: Pluslife SARS-CoV-2 Card Device ID: 2958 Method: Other Target: Nucleic acid Format: Near POC / POC, Semi-automated Go to details
CE Marking: No Manufacturer: Guangzhou Supbio Biotechnologies Inc. Commercial: Supbio SARS-CoV-2 (ORF1ab/N) (Nucleic Acid Detection Kit / PCR-Fluorescent) Device ID: 203 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Guangzhou Tebsun Bio-Tech Development Co. Ltd. Commercial: SARS-CoV-2 Nucleic Acid Test (LAMP) Device ID: 204 Method: LAMP Target: Nucleic acid Format: Automated, Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: SARS-CoV-2 Real-Time RT-PCR Assay Device ID: 1131 Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: No Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondfo SARS-CoV-2 Nucleic Acid Detection Kit Device ID: 205 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: HA TECH PTY Ltd. Commercial: SARS-CoV-2 RT-PCR Multiplex Diagnostic Kit (NAT-01) Device ID: 2698 Method: RT-PCR Target: Format: Lab-based Go to details
CE Marking: No Manufacturer: Hackensack Meridian Health CDI Commercial: SARS-COV-2 test Device ID: 207 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory Commercial: CDI Enhanced COVID-19 Test Device ID: 726 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Hain Lifescience a Bruker company Commercial: FluoroType® SARS-CoV-2 evo Device ID: 2972 Method: RT-PCR Target: Format: Semi-automated Go to details
CE Marking: Yes Manufacturer: Hain Lifescience a Bruker company Commercial: FluoroType® SARS-CoV-2 plus Device ID: 2880 Method: RT-PCR Target: Nucleic acid Format: Other, Semi-automated Go to details
CE Marking: Yes Manufacturer: Hain Lifescience a Bruker company Commercial: FluoroType® SARS-CoV-2 varID Q Device ID: 2970 Method: RT-PCR Target: Format: Semi-automated Go to details
CE Marking: Yes Manufacturer: Hain Lifescience a Bruker company Commercial: FluoroType® SARS-CoV-2/Flu/RSV Device ID: 2971 Method: RT-PCR Target: Format: Semi-automated Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: SARS-COV-2 RT-qPCR Assay Device ID: 1368 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Hangzhou Bigfish Bio-tech Co. Ltd. Commercial: LAMP kit for qualitative detection of SARS-CoV-2 Device ID: 210 Method: LAMP Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Hangzhou Bigfish Bio-tech Co. Ltd. Commercial: The golden standard of SARS-CoV-2 viral nucleic acid detection Device ID: 211 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Bioer Technology Co. Ltd. Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR) Device ID: 1287 Method: RT-PCR Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Clongene Biotech Co. Ltd. Commercial: SARS-CoV-2 Nucleic Acid RT-PCR Test Kit Device ID: 1364 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Hangzhou Dan Wei Biotechnology Co. Ltd. Commercial: 2019-nCoV Direct RT-qPCR Kit Device ID: 213 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Dian Biotechnology Co. Ltd. Commercial: Real-time RT-PCR Detection Kit For 2019-nCoV Device ID: 569 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. Commercial: New Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent PCR Method) Device ID: 215 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: Hayat Genetics Inc. Commercial: Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit Device ID: 1230 Method: LAMP Target: Nucleic acid Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Hibergene Commercial: HG COVID-19 Device ID: 216 Method: LAMP Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Hologic Commercial: Aptima SARS-CoV-2 Assay (Panther System) Device ID: 972 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: No Manufacturer: Hologic Commercial: Panther Fusion SARS-CoV-2 assay Device ID: 217 Method: RT-PCR Target: Nucleic acid Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Hong Kong University of Science and Technology Commercial: On-site rapid molecular diagnostic system based on Shenzhen Shineway Technology Device ID: 218 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: No Manufacturer: Huwel Lifesciences Pvt. Ltd. Commercial: Quantiplus CORONA Virus (2019nCoV) detection kit Device ID: 222 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