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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVIDsure Pro Multiplex RT PCR Kit

Manufactured by Trivitron Healthcare Pvt. Ltd, India - www.trivitron.com/ 

Device identification number
1119
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
samples from entire respiratory tract http://www.absology.co.kr/ https://www.trivitron.com/products/covid-19/covid-19-testing-kits/covidsure-pro-multiplex-rt-pcr-kit
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
60 minutes
LOD
5 copies/μl
Positive control
ORF 1ab, envelope (E), and nucleocapsid (N) + internal control
Analytical Sensitivity
100 %
Analitical Specificity
100 %
Type of antigen
nucleoprotein
Notes
https://www.trivitron.com/uploads/brochure/15946436444COVIDsure_Pro_eBrochure_13072020.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