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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cervical intraepithelial neoplasia (cin) test system
Regulation Description Cervical intraepithelial neoplasia (CIN) test system.
Definition The p16 CIN test system is a qualitative immunohistochemistry (IHC) test to assess the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. It is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of CIN. Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.
Product CodePRB
Regulation Number 864.1865
Device Class 2


Premarket Reviews
ManufacturerDecision
VENTANA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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