Cervical Intraepithelial Neoplasia (Cin) Test System
- US Product Code (FDA)
- PRBView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 864.1865View CFR Regulation →
- Medical specialty
- Pathology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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.
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Cervical Intraepithelial Neoplasia (Cin) Test System is a medical device type in the Pathology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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