CLART COVID-19
Manufactured by Genomica Sau, Spain - genomica.com/
Device identification number
186
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
validated at the National Center for Microbiology (Instituto de Salud Carlos III, Spanish National Reference Center) with a panel of 80 samples
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
300 minutes
Clinical Sensitivity
96 %
Clinical Specificity
98 %
Throughput
96 samples/run ( (probe microarrays))
Notes
http://genomica.com/covid-19/?lang=en
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