LabGun COVID-19 Assay
Manufactured by Labgenomics Co. Ltd., South Korea - http://www.labgenomics.co.kr/eng/
Device identification number
2354
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Strip
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Nasopharyngeal swab, Oropharyngeal swab, Sputum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The LabGunTM COVID-19 Assay is a real time RT-PCR in vitro diagnostic test intended for the qualitative detection of SARS-CoV-2 RNA from Sputum, Bronchoalveolar lavage fluid and Oropharyngeal, Nasopharyngeal swab specimens from individuals who meet COVID-19 clinical and/or epidemiological criteria.
Assay Type
Unknown
Rapid Diagnostic
No
Method
RT-PCR
Time
150 minutes
LOD
100 cpr
Clinical Sensitivity
100
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