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