| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: 1drop Inc. | Commercial: 1copy COVID-19 qPCR Kit | Device ID: 1 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc. | Commercial: 1copy™ COVID-19 MDx Kit Professional | Device ID: 2921 | Method: LAMP | Target: | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc. | Commercial: 1copy™ COVID-19 qPCR 4plex Kit | Device ID: 2920 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc. | Commercial: 1copy™ COVID-19 qPCR Multi Kit | Device ID: 2917 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc. | Commercial: 1copy™ COVID-19 qPCR Triplex Kit | Device ID: 2918 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc. | Commercial: 1copy™ COVID-19/FluA/FluB/RSV qPCR Kit | Device ID: 2919 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: 3B BlackBio Biotech India Ltd. | Commercial: TRUPCR SARS-CoV-2 RT qPCR Kit | Device ID: 3 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co. Limited | Commercial: ANDiS FAST SARS-CoV-2 RT-qPCR Detection Kit | Device ID: 2252 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 3D Medicines | Commercial: 2019-nCoV RT-qPCR | Device ID: 2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 3D Medicines | Commercial: 3DMed 2019-nCoV RT-qPCR Detection Kit | Device ID: 4 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: A*ccelerate | Commercial: A*STAR Fortitude Kit 2.0 | Device ID: 504 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: A*ccelerate | Commercial: A*STAR Fortitude Kit 2.0 (Singapore HSA) – PCR kit | Device ID: 13 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AAZ | Commercial: PRESTO 2019-nCoV Direct qPCR Kit | Device ID: 963 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY ABFlu-CoV-2 | Device ID: 2092 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Manual | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY RQ-2019-nCoV | Device ID: 5 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY RQ-2019-nCoV | Device ID: 2093 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY RQ-SARS-CoV-2 | Device ID: 2091 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY SARS-CoV-2 5G | Device ID: 3121 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Abacus Diagnostica | Commercial: GenomEra SARS-CoV-2 | Device ID: 7 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: Abbott ID NOW COVID-19 | Device ID: 496 | Method: Other | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: ABBOTT REALTIME SARS-COV-2 ASSAY | Device ID: 876 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Abbott | Commercial: Abbott RealTime SARS-CoV-2 EUA test | Device ID: 8 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Molecular Inc. | Commercial: Abbott RealTime SARS-CoV-2 | Device ID: 1041 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Molecular Inc. | Commercial: Alinity m SARS-CoV-2 AMP Kit | Device ID: 1042 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: abCyclerQd Realâ€time PCR System | Commercial: abCyclerQd Real‐time PCR System | Device ID: 3132 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Access Bio Inc. | Commercial: CareStart COVID-19 MDx RT-PCR | Device ID: 760 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Accuster Technologies Pvt Ltd. | Commercial: Accuster SARS-COV2-RT-PCR test kit | Device ID: 763 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Promotor SARS-CoV-2 RT-PCR Test Kit | Device ID: 1376 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories Inc. | Commercial: Promotor SARS-CoV-2 RT-PCR Test Kit | Device ID: 1799 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: SARS-COV-2 RT-qPCR Assay | Device ID: 1693 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Acumen Research Laboratories Pte Ltd. | Commercial: Acu-Corona | Device ID: 16 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Acumen Research Laboratories Pte Ltd. | Commercial: Acu-Corona 2.0 | Device ID: 15 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ADALTIS srl | Commercial: MOLgen SARSCoV2 Real Time RT PCR | Device ID: 508 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Addbio Meditek Co. | Commercial: AddMedi SARS-CoV-2 RT-qPCR Kit | Device ID: 2020 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: No | Manufacturer: ADT Biotech | Commercial: LyteStar 2019-nCoV RT-PCR Kit 1.0 | Device ID: 17 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Advanced Biological Laboratories SA | Commercial: UltraGene Combo2Screen SARS-CoV-2 Assay | Device ID: 764 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Advanced Molecular Diagnostics | Commercial: AMD Human SARS-CoV-2 detection kit | Device ID: 19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AgenaBioscience Inc. | Commercial: MassARRAY SARS-CoV-2 Panel | Device ID: 1396 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: AITbiotech | Commercial: abTES COVID-19 qPCR I Kit | Device ID: 468 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: AITbiotech | Commercial: abTES™ Qd COVID‐19 qPCR I Kit | Device ID: 3131 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AITBIOTECH PTE Ltd. | Commercial: abTES COVID-19 Variant qPCR I Kit | Device ID: 3119 | Method: RT-PCR | Target: | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AITBIOTECH PTE Ltd. | Commercial: abTES™ Flu/COVID-19 qPCR I Kit | Device ID: 3129 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Aldatu Biosciences | Commercial: PANDAA qDx SARS-CoV-2 | Device ID: 20 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Altona Diagnostics | Commercial: RealStar SARS-CoV-2 RT-PCR Kit | Device ID: 22 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amazing Biotech (Shanghai) Co. Ltd. | Commercial: Ultrafast Twinblock 8 Wells Real Time PCR Instrument | Device ID: 4080 | Method: RT-PCR | Target: RNA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Amedica SA | Commercial: Amela SARS CoV-2 Real time PCR Detection kit | Device ID: 831 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amoy Diagnostics Co. Ltd. | Commercial: AmoyDx Novel Coronavirus (2019 nCoV) Detection Kit | Device ID: 29 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Amplicon Ltd. | Commercial: AmpliTest SARS-CoV-2 (Real Time PCR) | Device ID: 509 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: COVID-19 Lyophilised Nucleic Acid Kit | Device ID: 1052 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Anatolia Geneworks | Commercial: Bosphore Novel Coronavirus (2019-nCoV) Detection Kit | Device ID: 31 | 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