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TPLC - Total Product Life Cycle
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Device high throughput dna sequencing for hereditary cancer predisposition assessment test system.
Definition A high throughput DNA sequencing for hereditary cancer predisposition assessment test system is a qualitative in vitro diagnostic (IVD) system intended for analysis of human DNA extracted from human specimens to detect germline mutations in a panel of targeted cancer related genes. It is intended to aid in hereditary cancer predisposition assessment by qualified health care professionals in accordance with professional guidelines. The device is not intended for screening, prenatal testing or as a stand-alone diagnostic test. The device is for prescription use only.
Product CodeQVU
Regulation Number 866.6095
Device Class 2


Premarket Reviews
ManufacturerDecision
INVITAE CORPORATION
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