2019 Novel Coronavirus Real-time PCR Kit
Manufactured by Kogene Biotech, South Korea - www.kogene.co.kr/eng/
Device identification number
730
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
Comments
Based on WHO and CDC reference methods
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Positive control
E gene, RdRp. Internal control
Notes
http://www.kogene.co.kr/eng/about_us/news/listbody.php?h_gcode=board&h_code=7&po_no=288
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