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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)
2019 2020 2021 2022 2023 2024
3 1 3 5 1 0

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Emotional Changes 1 1

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