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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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 (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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