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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids
Definition A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product.
Product CodeSBY
Regulation Number 866.6085
Device Class 2


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ManufacturerDecision
PERSONAL GENOME DIAGNOSTICS, INC.
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