WizDx COVID-9 Real-time PCR Kit
Manufactured by Wizbio Solutions, South Korea - www.wizbiosolution.com
Device identification number
954
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
15.3 copies/rxn (RdRP gene)
LOD
14.4 copies/rxn (E gene)
Negative control
nuclease-free water
Analitical Specificity
100 %
Type of antigen
nucleoprotein
Notes
https://b34516c8-fef7-4fb9-8285-73f5f0d49c30.usrfiles.com/ugd/b34516_e08887f0b6014b4f86b0b9e0b3e0e306.pdf
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