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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 PCR DIATHEVA Detection kit

Manufactured by Diatheva SRL, Italy - www.diatheva.com 

Device identification number
148
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
Subclass
RdRP_SARSr
Positive control
RNase P target as internal positive controlpositive control sample
Negative control
no template tube
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
single tubes
Notes
https://www.diatheva.com/images/DATASHEET/MBK_MBR/MBK0091%20COVID-19%20Pcr%20Diatheva%20Detection%20Kit.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