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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cancer-related germline gene mutation detection system
Definition The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens.
Product CodePJG
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
3 5 3 1 3 2

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