| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: 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: 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: 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 | Device ID: 2354 | 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: 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: 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: Luminex Molecular Diagnostics Inc. | Commercial: NxTAG® Respiratory Pathogen Panel + SARS-CoV-2 | Device ID: 2518 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | 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 |
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: LumiraDx SARS-CoV-2 RNA STAR Complete | Device ID: 2645 | Method: RT-PCR | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: SARS-CoV-2 & Flu A/B RNA STAR Complete | Device ID: 3840 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Luxus Lebenswelt GMBH (Beijing NaGene Diagnosis Reagent Co. Ltd.) | Commercial: COVID-19 mouth and throat Swab | Device ID: 961 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mabsky Bio-Tech Co. Ltd. | Commercial: COVID-19 virus (2019-nCoV) Dual-Detection Kit | Device ID: 269 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mabsky Bio-Tech Co. Ltd. | Commercial: COVID-19 virus (2019-nCOV) Triple-Detection Kit (Real-Time PCR Method) | Device ID: 271 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mabsky Bio-Tech Co. Ltd. | Commercial: Influenza A virus, Influenza B virus & COVID-19 virus (2019-nCoV) Triple-Detection Kit | Device ID: 270 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Fluorescent PCR | Device ID: 272 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Fluorescent PCR Kit | Device ID: 1916 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Medical Innovation Ventures Sdn Bhd. | Commercial: GenoAmp Real-Time RT-PCR SARS-CoV-2 | Device ID: 275 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: Coronavirus Disease 2019 Real Time PCR Kit | Device ID: 2051 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Medigen Vaccine Biologics Corp. | Commercial: MVC SARS-CoV-2 Real-Time PCR Diagnostic Kit | Device ID: 582 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Medisys International SA Gmate Covid-19 | Commercial: Gmate Covid-19 | Device ID: 862 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: Meril COVID-19 One-step RT-PCR Kit | Device ID: 792 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Meslo | Commercial: COVID-19 qPCR kit | Device ID: 897 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Detection Kit, nCoV-OS | Device ID: 2795 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Detection Kit, nCoV-QS | Device ID: 2794 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-OM | Device ID: 2797 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-QM | Device ID: 2796 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-QM-N | Device ID: 2799 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-VM | Device ID: 2798 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: Veri-Q COVID-19 & Flu A/B Multiplex Detection Kit | Device ID: 2801 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: VERI-Q PCR 316 COVID-19 detection system | Device ID: 280 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: ampliCube Coronavirus Panel | Device ID: 282 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: ampliCube Coronavirus SARS-CoV-2 | Device ID: 281 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mobidiag | Commercial: Amplidiag COVID-19 | Device ID: 935 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Mobidiag | Commercial: Novodiag COVID-19 | Device ID: 936 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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