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QKFClass III

Immunocytochemistry Assay, P16/Ki-67

21 CFR 864.1860 / Hematology
FDA source (opens on fda.gov)

QKF is the FDA product code for Immunocytochemistry Assay, P16/Ki-67, a class III device type, regulated under 21 CFR 864.1860. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QKF
Device name
Immunocytochemistry Assay, P16/Ki-67
FDA 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.
Regulation
21 CFR 864.1860
Device class
Class III
Review panel
Hematology
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code