QFK · Tumor Gene Profiling Test

· Class N

Overview

Product CodeQFK
Device NameTumor Gene Profiling Test
Device ClassClass N
Review Panel

Identification

A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from nucleic acids isolated from human clinical specimens obtained from patients diagnosed with malignant neoplasms using targeted next-generation sequencing.

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