Immunocytochemistry Assay, P16/Ki-67

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown