| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: No | Manufacturer: Mammoth Biosciences | Commercial: SARS-CoV-2 DETECTR | Device ID: 273 | Method: CRISPR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MD-Bio Inc. | Commercial: MD-Bio BCC19 Test Kit | Device ID: 2952 | Method: LAMP | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Medical & Biological Laboratories Co. Ltd. | Commercial: FLUOROSEARCH Novel Coronavirus (SARS-CoV-2) Detection Kit | Device ID: 274 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: No | Manufacturer: Medigen Vaccine Biologics Corp. | Commercial: MVC SARS-CoV-2 Convective PCR Diagnostic Device/Kit | Device ID: 581 | 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: No | Manufacturer: MedStar Medical Co. Ltd. | Commercial: One-step Direct Realtime PCR Test Kit of 2019-nCoV Coronavirus | Device ID: 278 | 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: No | Manufacturer: Mesa Biotech | Commercial: Accula SARS-CoV-2 test | Device ID: 736 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: No | Manufacturer: MGI Tech Co. Ltd. | Commercial: Fast SARS-CoV-2 NAT with CRISPR assay by digital microfluidics automation | Device ID: 483 | Method: CRISPR | Target: Nucleic acid | Format: Lab-based, Near POC / POC | 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: No | Manufacturer: MicroGenDx | Commercial: COVID-19 Key | Device ID: 737 | 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 |
| CE Marking: No | Manufacturer: Mobidiag | Commercial: Novodiag COVID-19 + InfA/B | Device ID: 283 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Molbio Diagnostics Private Limited | Commercial: Truenat® COVID-19 | Device ID: 2913 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Molbio Diagnostics Private Limited | Commercial: Truenat® SARS CoV-2 | Device ID: 286 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Molgentix S.L. | Commercial: CoviNplex™ One Step RT-PCR Kit For qualitative detection of SARS-CoV-2 assay | Device ID: 2176 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Monocent Inc. | Commercial: SARS-CoV2 RT-PCR | Device ID: 1330 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: RapidScript SARS-CoV-2 Assay | Device ID: 1127 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19 qPCR Allplex | Device ID: 2027 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTest COVID-19 qPCR ALLPLEX Kit | Device ID: 1692 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTest COVID-19 qPCR MULTIPLEX | Device ID: 1315 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19 qPCR Rapid Kit | Device ID: 2859 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19 qPCR SuperRapid Kit | Device ID: 3156 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: rTEST COVID-19/FLU qPCR DIAGNOSTIC KIT | Device ID: 1332 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: vDetect COVID-19 RT-qPCR diagnostic kit | Device ID: 1077 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MultiplexDX s.r.o. | Commercial: Vivid COVID-19 LAMP Direct-G | Device ID: 2960 | Method: LAMP | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Ag Qualitative PCR Kit | Device ID: 2358 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Qualitative PCR Kit | Device ID: 288 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, 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