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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 CE IVD qPCR assay

Manufactured by AssayGenie, Ireland - www.assaygenie.com 

Device identification number
891
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
LOD
200 copies/ml
Positive control
RNA pseudovirus containing target gene
Negative control
DEPC-Treated Water
Analytical Sensitivity
100 %
Analitical Specificity
100 %
Notes
https://www.assaygenie.com/2019-novel-coronavirus-2019-ncov-triplex-rt-qpcr-detection-kit/

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