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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Molecision SARS-CoV-2 RT-PCR Assay

Manufactured by Snibe Co. Ltd., China - www.snibe.com/ 

Device identification number
1206
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://drive.google.com/file/d/1CjDDY-GFr-xq4CELYS2ja_ts2B7shgit/view?usp=sharing
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Positive control
Pseudo-Viruses of target virus gene and internal control
Negative control
Nase-free water
Clinical Specificity
100 %
Type of antigen
nucleoprotein
Notes
https://drive.google.com/file/d/1CjDDY-GFr-xq4CELYS2ja_ts2B7shgit/view?usp=sharing

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