Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit
Manufactured by Bioeksen R&D Technologies Ltd - https://bioeksen.com.tr/
Device identification number
525
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-03-26 02:28:45
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
5.6 copies/reaction ()
Positive control
Wuhan-RdRp positive control
Analytical Sensitivity
99 % ()
Analitical 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