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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

LabGun COVID-19 ExoFast RT-PCR Kit

Manufactured by Labgenomics Co. Ltd., South Korea - http://www.labgenomics.co.kr/eng/ 

Device identification number
2351
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The LabGunTM COVID-19 ExoFast RT-PCR Kit is an in vitro diagnostic test, based on real-time reverse transcription PCR technology, for the amplification and detection of RdRp gene and N gene of SARS-CoV-2 from Sputum and Oropharyngeal, Nasopharyngeal swab. The Kit aids to diagnose COVID-19.
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
40 minutes
LOD
50 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