Kewei COVID-19 RT-PCR Test Kit
Manufactured by Beijing Kewei Clinical Diagnostic Reagent Inc., China - en.keweidiagnostic.com/
Device identification number
832
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Fluorescence quantitative PCR instrument; Specimen?Throat /Nasal Swab; 50T/kit; qualitative detection of SARS-CoV-2 nucleic acids http://en.keweidiagnostic.com/index.php?m=content&c=index&a=show&catid=199&id=174
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
120 minutes
Detection Principle
Fluorescence
Analytical Sensitivity
93.3 %
Analytical Specificity
100 %
Notes
Manual or automated
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