Product code QKF

Device name

Immunocytochemistry Assay, P16/Ki-67

Medical specialty

Hematology

Device class

3

Regulation number

864.1860

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset