Fast Track Diagnostics (FTD) SARS-CoV-2 Assay
Manufactured by Siemens Healthineers, Germany - www.siemens-healthineers.com
Device identification number
747
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
180 minutes
Clinical Sensitivity
100 (CI95%: 91.8-100)
Clinical Specificity
100 (CI95%: 93.8-100)
Notes
https://www.siemens-healthineers.com/press-room/press-releases/test-kit-for-coronavirus-covid-19-ce-ivd.html
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