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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR)

Manufactured by Genrui Biotech Inc., China - www.genrui-bio.com 

Device identification number
1925
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Oropharyngeal swab, Sputum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The N, S and ORF1ab genes of Novel Coronavirus (2019-nCoV) are selected as target region.
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
200 cpu
Clinical Sensitivity
98.84 %
Clinical Specificity
100 %

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