Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR)
Manufactured by Genrui Biotech Inc. - http://www.genrui-bio.com/
Device identification number
1925
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Specimen
Oropharyngeal swab, Sputum
Commercial Status
Commercialised
Last Update
03/25/2021 04:03
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