GCdia™ COVID-19 Fast Detection Kit
Manufactured by Genes Laboratories, South Korea - http://www.geneslabs.com/
Device identification number
25578
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Strip
Target type
Nucleic acid
Targets
Other (RdRp gene, N gene)
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
MERS-CoV
Pathogens detected
SARS-CoV-2
Lineages detected
Commercial Status
Commercialised
Last Update
2023-07-06 05:00:30 CET
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
N.A.
Self Test
No
Reader Required
Yes
Subcategory
N.A.
Method
RT-PCR
Measurement
Qualitative
Time
40 minutes
Subclass
Multiple
Detection Principle
Fluorescence
Clinical Sensitivity
99.09 %
Clinical Specificity
98.18 %
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