Immunocytochemistry Assay, P16/Ki-67
- US Product Code (FDA)
- QKFView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 864.1860View CFR Regulation →
- Medical specialty
- Hematology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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.
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Immunocytochemistry Assay, P16/Ki-67 is a medical device type in the Hematology 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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