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: Yes | Manufacturer: 3D Biomedicine Science & Technology Co. Limited | Commercial: 96A Viral RNA Auto Extraction & Purification Kit | Device ID: 2254 | Method: | Target: Nucleic acid | Format: | 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 Biomedicine Science & Technology Co. Limited | Commercial: ANDiS Viral RNA Auto Extraction & Purification Kit | Device ID: 2253 | Method: | Target: Nucleic acid | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: 3D Biomedicine Science & Technology Co. Limited | Commercial: Sample Transport Medium | Device ID: 2255 | Method: | Target: Nucleic acid | Format: | 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: Yes | Manufacturer: A PLUS DIAGNOSTICS LAB.SAN.TIC.A.S. | Commercial: SMARAPIDTEST | Device ID: 1344 | Method: Immunoassay | Target: Antibody, Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: A PLUS DIAGNOSTICS LAB.SAN.TIC.A.S. | Commercial: SMARTTEST SARS-COV-2 NASOPHARYNGEAL ANTIGEN RAPID TEST | Device ID: 2985 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: A&B Professional | Commercial: A&B RAPID TEST COVID-19 IGG/IGM CASSETTA | Device ID: 1004 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: A. Menarini Diagnostics | Commercial: ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB) | Device ID: 1608 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AAZ | Commercial: Covid PRESTO Test rapide COVID-19 IgG/IgM | Device ID: 964 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: AAZ-LMB | Commercial: COV-QUANTO | Device ID: 1834 | Method: ELISA | Target: Antigen | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-PRESTO | Device ID: 1835 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-VIRO | Device ID: 1833 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-VIRO ALL IN | Device ID: 3037 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-VIRO ALL IN TRIPLEX | Device ID: 3975 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: 2093 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | 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-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: AB Dianostic Systems GmbH | Commercial: abia SARS-CoV- IgG/IgM | Device ID: 913 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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 | Commercial: SARS-CoV-2 IgG | Device ID: 701 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Abbott Ireland Diagnostics Division | Commercial: SARS-CoV-2 IgG II Quant | Device ID: 2773 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Abbott Ireland Diagnostics Division | Commercial: SARS-CoV-2 IgM | Device ID: 2774 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated | 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: Abbott Rapid Diagnostics | Commercial: Panbio Covid-19 Ag Rapid Test | Device ID: 1232 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | 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: Abingdon Health Plc | Commercial: AbC-19 Rapid Test | Device ID: 1992 | Method: Immunoassay | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Abingdon Health Plc | Commercial: AbC-19 Semi-Q Rapid Test | Device ID: 2879 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Abionic SA | Commercial: IVD CAPSULE COVID-19-NP | Device ID: 2975 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Abionic SA | Commercial: IVD CAPSULE COVID-19-SS | Device ID: 2993 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Abioteq GmbH | Commercial: Cora Gentest-19 | Device ID: 2374 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 Ag | Device ID: 1982 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 Ag Rapid | Device ID: 1981 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 IgM/IgG Combo | Device ID: 1302 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 IgM/IgG Rapid | Device ID: 1151 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 NAb | Device ID: 1983 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC, 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