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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

PCLMD nCoV one step RT-PCR Kit

Manufactured by PCL Inc, South Korea - www.pclchip.com/ 

Device identification number
593
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
105 minutes
Clinical Sensitivity
100%
Notes
http://pclchip.com/eng/sub_n4/4_6.php?mode=view&number=783&page=1&b_name=eng_notice

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