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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

quanty-CONV-19

Manufactured by Clonit, Italy - www.clonit.it/en/ 

Device identification number
129
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
LOD
1 copies/μl
Positive control
Inhibition control, positive controls (synthetic RNA)
Negative control
Not found
Analytical Specificity
Tested negative with samples tested as positive for other viruses
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
single tubes
Notes
http://newsletter.biozol.de/Mail/Bilder/Webseite/COVID-19%20Produkte/RT-25.5%20(ENG).pdf

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