QKF

Immunocytochemistry Assay, P16/Ki-67

Product code: QKF
Device name: Immunocytochemistry Assay, P16/Ki-67
Device class: Class 3
21 CFR: 21 CFR 864.1860
Medical specialty: Hematology
Marketing pathway: PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QKF

Classification and pathway per current FDA publications. Data from openFDA (CC0).