QKF
- 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.
Official FDA classification page: QKF
Classification and pathway per current FDA publications. Data from openFDA (CC0).