Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Simplexa COVID-19 Direct RT-PCR Kit

Manufactured by DiaSorin S.p.A, Italy - www.diasorin.com/ 

Device identification number
471
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
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
60 minutes
LOD
500 copies/ml
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
single tubes
Notes
https://molecular.diasorin.com/international/kit/simplexa-covid-19-direct-kit/

Related Scientific Literature

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