Immunocytochemistry Assay, P16/Ki-67
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.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.
US Regulatory Classifications
Device Characteristics
No
No
No
Not Eligible
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.
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