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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

careGENE N-CoV RT-PCR kit

Manufactured by Wells Bio Inc., South Korea - www.wellsbio.net/eng/ 

Device identification number
494
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
Includes information about reproducibility
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
83 minutes
LOD
5 copies/μl
Positive control
positive and internal control
Analytical Specificity
tested negative with 16 species of microorganisms
Notes
https://www.apacor.com/products/caregene-n-cov-rt-pcr-kit/

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