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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, immunity, cell mediated, mycobacterium tuberculosis
Product CodeNCD
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
6 6 6 8 6 4

MDR Year MDR Reports MDR Events
2020 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2 2
No Known Impact Or Consequence To Patient 1 1

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