GeneFinder COVID-19 Fast RealAmp Kit
Manufactured by OSANG Healthcare Co. Ltd., South Korea - http://www.osanghc.com/en
Device identification number
1591
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Sputum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Manual NAT
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Qualitative
Time
50 minutes
LOD
2 cpm
Positive control
Positive Control Reagent
Negative control
Negative Control Reagent
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples/run
Notes
Manual NAT
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