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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tumor gene profiling test
Definition 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.
Product CodeQFK
Device Class Not Classified

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