Kaira 2019-nCoV Detection kit
Manufactured by OPTOLANE Technologies Inc., South Korea - www.optolane.com/
Device identification number
794
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
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
80 minutes
LOD
1.38 copies/μl (for E-gene)
LOD
6.46 copies/μl (for RdR)
Positive control
E-gene, RdRP gene
Notes
http://optolane.com/wp-content/uploads/2020/04/4-Kaira-2019-nCoV-Detection-kit-leaflet-0413-copy-Web-Version.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