SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescence Probe Method)
Manufactured by Beijing Lepu Medical Technology Co. Ltd., China - https://www.lepumedical.com/
Device identification number
1859
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
NO
Assay Type
Nucleic acid-PCR
Method
Other ()
Positive control
96.6 %
Clinical Sensitivity
92 %
Clinical Specificity
100 %
Notes
fluorescence detection
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