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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

vDetect COVID-19 RT-qPCR diagnostic kit

Manufactured by Eset Ltd., United Kingdom - www.eset.com 

Device identification number
956
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
Data provided by Manufacturer
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
180 minutes
LOD
8 cpr ((1.6 cpu))
Positive control
full genomic RNA od coronavirus SARS Cov2
Negative control
pcr water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples per run
Notes
https://www.eset.com

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