The 29 Somatic Mutations Detection Kit in the EGFR Gene - Vietnam Registration 2301689ĐKLH/BYT-HTTB
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Device Details
Registration Details
2301689ĐKLH/BYT-HTTB
000.00.04.G18-200826-0027
therascreen® EGFR RGQ PCR Kit
874111
Technical Details
therascreen EGFR RGQ PCR Kit is an in vitro diagnostic test to detect 29 somatic mutations in the EGFR gene. The test provides a qualitative assessment of the mutation status in tumor tissue samples from patients with non-small cell lung cancer (NSCLC). The results aim to support the clinical decision-making process in identifying NSCLC patients who may benefit from EGFR tyrosine kinase inhibitor therapy. therascreen EGFR RGQ PCR Kit will test DNA samples extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue from NSCLC patients and run on the Rotor-Gene Q MDx 5plex HRM device. The test must be performed by trained laboratory personnel. therascreen EGFR RGQ PCR Kit is designed for in vitro diagnostic use.
Dates and Status
Dec 22, 2023

