Molecision SARS-CoV-2 & Flu A/B RT-PCR Assay
Manufactured by Snibe Co. Ltd., China - www.snibe.com/
Device identification number
1492
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
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
120 copies/ml
Positive control
97 %
Negative control
100 %
Analytical Sensitivity
97.4 %
Analytical Specificity
100 %
Clinical Sensitivity
97.4 %
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