# Immunocytochemistry Assay, P16/Ki-67
> **Product code: QKF** · Class III — High Risk (PMA approval required, life-sustaining) · Hematology · 21 CFR 864.1860
## Classification
- **FDA Product Code:** QKF
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 864.1860
- **Review panel:** PA
- **Medical specialty:** Hematology
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QKF)
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