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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Genedrive 96 SARS-CoV- Kit

Manufactured by genedrive, United Kingdom - www.genedrive.com/ 

Device identification number
925
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
Time
100 minutes
LOD
0.5 copies/μl
Analytical Sensitivity
100 %
Analytical Specificity
98.2 %
Throughput
96 reactions

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