| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Genesystem Co. Ltd. | Commercial: SMARTCHEK SARS-CoV2 Detection Kit | Device ID: 853 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic Analysis AS | Commercial: GA-map COVID-19 Fecal Test | Device ID: 1171 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic PCR Solutions | Commercial: CoVID-19 dtec-RT-qPCR Test | Device ID: 1207 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic PCR Solutions | Commercial: CoVID-19 dtec-RT-qPCR-Test | Device ID: 1157 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetron | Commercial: Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing) | Device ID: 722 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri | Commercial: geneMAP 2019-nCoV (SARS-CoV-2) Detection Kit | Device ID: 1222 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri | Commercial: geneMAP 2019-nCoV (SARS-CoV-2) Rapid Detection Kit | Device ID: 1059 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri | Commercial: geneMAP Respiratory Viral PCR Panel 2 (2019-nCoV, Inf A/B, RSV A/B) | Device ID: 1221 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genobio Pharmaceutical Co. Ltd. | Commercial: Virusee® SARS-CoV-2 Molecular Detection Kit (Real-time RT-PCR) | Device ID: 2752 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: CLART COVID-19 | Device ID: 186 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: qCOVID-19 | Device ID: 185 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genomictree Inc. | Commercial: AccuraTect RT-qPCR SARS-CoV-2 | Device ID: 187 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: 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: 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 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: 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: 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: Yes | Manufacturer: GVS S.p.A. | Commercial: Flame CoViD -19 VARIANTS qPCR Master Kit – CE-IVD | Device ID: 2445 | Method: RT-PCR | Target: | Format: Fully automated (robot), Lab-based, Manual, Semi-automated | 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: 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: 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: 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: Yes | Manufacturer: Hangzhou LifeReal Biotechnology Co. Ltd. | Commercial: LifeReady 1000 automatic integrated gene detection system | Device ID: 2556 | Method: RT-PCR | Target: | Format: Automated, Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: Hibergene | Commercial: PCR Adapt COVID-19 | Device ID: 2739 | Method: RT-PCR | Target: | 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: 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: Yes | Manufacturer: HymonBio Co. Ltd. | Commercial: Hymon Respiratory Triplex Panel Test Kit | Device ID: 3030 | Method: RT-PCR | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: HymonBio Co. Ltd. | Commercial: Hymon SARS-CoV-2 Test Kit | Device ID: 3002 | Method: RT-PCR | Target: | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Hyris Limited | Commercial: bKIT Virus Finder COVID-19 | Device ID: 2513 | Method: RT-PCR | Target: Nucleic acid | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Imegen | Commercial: Imegen SARS-CoV-2 | Device ID: 789 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Imegen | Commercial: Imegen SARS-CoV-2 plus | Device ID: 1115 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immundiagnostik AG | Commercial: MutaPLEX® Coronavirus Real-Time-RT-PCR-Kit | Device ID: 2014 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immundiagnostik AG | Commercial: MutaPLEX® CoV-2 MUT real time RT-PCR Kit | Device ID: 1850 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Genespark SARS-CoV2 Quantitative detection of SARS-CoV2 genome | Device ID: 1905 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: InActiv Blue | Commercial: InActiv Blue Swab Collection Tube | Device ID: 2679 | Method: RT-PCR | Target: | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Industrial Technology Research Institute Medical Device GMP Manufacturer | Commercial: iPMx Nucleic Acid Analyzer | Device ID: 3122 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ingenetix | Commercial: ViroReal Kit SARS-CoV-2 & SARS | Device ID: 788 | 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