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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunocytochemistry assay, p16/ki-67
Regulation Description Immunohistochemistry reagents and kits.
Definition The p16 and Ki-67 antibody cocktail is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a (E6H4) and Ki-67 (274-11AC3V1) proteins in cervical specimens collected by a clinician.
Product CodeQKF
Regulation Number 864.1860
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
2 3 3 1 3 0

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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