| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: 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: No | Manufacturer: InBios International | Commercial: InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit | Device ID: 224 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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 |
| CE Marking: No | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiple Fluorescence PCR) | Device ID: 226 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Institute of Chemical Biology and Fundamental Medicine | Commercial: LAMP kit for qualitative detection of SARS-CoV-2 | Device ID: 223 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Institute of Process Engineering Chinese Academy of Sciences | Commercial: Coronavirus Disease 2019 (COVID-19) Nucleic Acid Testing Kit (CAMP-based) | Device ID: 479 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Integrated DNA Technologies/Danaher | Commercial: SARS-CoV-2 (2019-nCoV) CDC qPCR Probe Assay | Device ID: 231 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Integrity Laboratories | Commercial: SARS-CoV-2 Assay | Device ID: 727 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: intron biotechnology | Commercial: LiliF COVID-19 Real-time RT-PCR Kit | Device ID: 480 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Iontek | Commercial: Fluorion nCoV-19 QLP 2.1 Real-Time PCR Kit | Device ID: 1721 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Other, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Ipsum Diagnostics | Commercial: COV-19 IDx assay | Device ID: 728 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: IVDbio Inc. | Commercial: Machine-Free, Fast and Accurate Nucleic Acid Diagnoses System for COVID-19 | Device ID: 232 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: PerfectQ COVID-19 Coronavirus Real Time PCR Kit | Device ID: 234 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu CoWin Biotech | Commercial: SARS-CoV-2 Detection Kit (qPCR Probe Assays) | Device ID: 1405 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Microdiag Biomedicine Technology Co. Ltd. | Commercial: Detection of 2019 novel coronavirus (2019-nCoV) by LFD RT-RAA | Device ID: 237 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Microdiag Biomedicine Technology Co. Ltd. | Commercial: Novel coronavirus 2019-nCoV nucleic acid detection kit (rRT- PCR method) | Device ID: 238 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: 2019-Novel Coronavirus (ORF1ab, E &N genes) Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay) | Device ID: 1619 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: 2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay | Device ID: 1621 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience Co. Ltd. | Commercial: 2019-Novel Coronavirus, Influenza Virus, Respiratory Syncytial Virus Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay) | Device ID: 1623 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Qitian Gene Biotechnology Co. Ltd. | Commercial: Fluorescent RAA Detection for 2019-nCoV | Device ID: 239 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Jiangxi YeLi Medical | Commercial: Apparatus Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing) | Device ID: 658 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: JN Medsys | Commercial: ProTect Covid-19 RT-qPCR kit | Device ID: 932 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: K.K. Mirai Genomics | Commercial: LifePad Analyzer | Device ID: 2899 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: K.K. Mirai Genomics | Commercial: Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method | Device ID: 2898 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: KH Medical Co. Ltd. | Commercial: RADI COVID-19 Detection Kit and RADI COVID-19 Triple Detection Kit | Device ID: 245 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: 2019 Novel Coronavirus Real-time PCR Kit | Device ID: 730 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: PowerChek 2019-nCoV Real-time PCR Kit | Device ID: 246 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: KRISHGEN BioSystems | Commercial: SARS-CoV-2 (Covid-19) Real-Time PCR Kit (as per CDC Atlanta guidelines) | Device ID: 250 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Krosgen Biotech | Commercial: KrosQuanT SARS-COV- 2 (2019 nCOV) Realtime PCR Kit | Device ID: 576 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co. Ltd. | Commercial: LabGun COVID-19 Assay plus | Device ID: 2353 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co. Ltd. | Commercial: LabGun COVID-19 ExoFast RT-PCR Kit | Device ID: 2351 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Labgenomics Co. Ltd. | Commercial: LabGun COVID-19 RT-PCR Kit | Device ID: 2352 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Laboratory Corporation of America | Commercial: LabCorp 2019 Novel Coronavirus test | Device ID: 255 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Landcent Europe B.V. | Commercial: Real time RT-PCR Kit for the detection of SARS-CoV-2 | Device ID: 256 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Langfang Xinruikang Biotechnology Co. Ltd. | Commercial: COVID-19 Nucleic Acid Detection Kit (RT-LAMP) | Device ID: 3091 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Liferiver | Commercial: Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCRT kit | Device ID: 260 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Liming Bio-Products Co. Ltd. | Commercial: SrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit | Device ID: 262 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: LLC EMG- Evotech Mirai Genomics | Commercial: SmartAmp SARS-CoV-2 RNA detection test kit | Device ID: 1951 | Method: | Target: Nucleic acid | Format: Manual, Other, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Lucira Health | Commercial: Lucira COVID-19 All-In-One Test Kit | Device ID: 1374 | Method: LAMP | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Lumex Instruments | Commercial: Microchip RT-PCR COVID-19 detection system | Device ID: 580 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Luminex Corp. | Commercial: ARIES SARS-CoV-2 Assay | Device ID: 481 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Luminex Corp. | Commercial: NxTAG CoV Extended Panel | Device ID: 266 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: Dual-Target SARS-CoV-2 STAR Complete | Device ID: 3924 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Semi-automated | 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