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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit

Manufactured by Bioeksen R&D Technologies Ltd., Turkey - www.bioeksen.com.tr 

Device identification number
525
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
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
5.6 copies/reaction
Positive control
Wuhan-RdRp positive control
Analytical Sensitivity
99 %
Analytical Specificity
99.4 %
Notes
https://bioeksen.com.tr/tr/covid-19-rt-qpcr-tespit-kiti/

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