| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: 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: 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 |
| CE Marking: Yes | Manufacturer: Nanjing Liming BioProducts Co. Ltd. | Commercial: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) | Device ID: 1224 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit | Device ID: 291 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: NanoBio Lab A*STAR Research Entities | Commercial: Isothermal Exponential Amplification for COVID-19 Detection | Device ID: 292 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Nationwide Children's Hospital | Commercial: SARS-CoV-2 Assay | Device ID: 739 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Navid | Commercial: COVID-19 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method) | Device ID: 326 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: NeuMoDx Molecular | Commercial: NeuMoDx SARS-CoV-2 Assay | Device ID: 740 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Next Pharma Inc. | Commercial: DiaCarta's QuantiVirusTMSARS-CoV-2 Test | Device ID: 295 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Ningbo Health Gene Technologies Co. Ltd. | Commercial: SARS-CoV-2 Virus Detection Diagnostic Kit (RT- qPCR Method) | Device ID: 296 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Norgen Biotek Corp. | Commercial: 2019-nCoV TaqMan RT-PCR Kit (Catalog# TM67100) | Device ID: 298 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: 2019-nCoV TaqMan RT-PCR Kit Dx (DxTM67100) | Device ID: 1158 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Norgen Biotek Corp. | Commercial: COVID19 TaqMan RT-PCR Kit Dx (E-RdRP genes) (DxTM67200) | Device ID: 1160 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: NorthShore University HealthSystem | Commercial: Novel Coronavirus test | Device ID: 299 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Northwell Health | Commercial: 2019 Novel Coronavirus PCR | Device ID: 300 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaPrime SARS-CoV- (COVID-19) | Device ID: 940 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaPrime® Plus SARS-CoV-2 | Device ID: 2321 | Method: RT-PCR | Target: | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaType II SARS-CoV-2 | Device ID: 2322 | Method: RT-PCR | Target: | Format: Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Nuclear Laser Medicine srl | Commercial: SArs-CoV-2 Real Time | Device ID: 2296 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: NY State Department of Health | Commercial: New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel | Device ID: 302 | Method: RT-PCR | Target: IgA, IgG, IgM, Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: NZYTech | Commercial: SARS-CoV-2 One-Step RT-PCR Kit | Device ID: 1927 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: OACP S.R.L. | Commercial: Corona Virus Disease 2019 (CoViD-19) Nucleic Acid Detection Kit | Device ID: 967 | 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