NKFClass III

Immunohistochemistry Antibody Assay, C-Kit

21 CFR 864.1860 / Hematology

NKF is the FDA product code for Immunohistochemistry Antibody Assay, C-Kit, a class III device type, regulated under 21 CFR 864.1860. FDA's definition for this code reads: "Identification/Intended Use - The anti-c-KIT primary antibody is intended for laboratory use, via light microscopy, for the qualitative detection of KIT protein in formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs) using either an automated immunohistochemistry staining system or manual assay...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: NKF
Device name: Immunohistochemistry Antibody Assay, C-Kit
FDA definition: Identification/Intended Use - The anti-c-KIT primary antibody is intended for laboratory use, via light microscopy, for the qualitative detection of KIT protein in formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs) using either an automated immunohistochemistry staining system or manual assay. It is indicated as an aid in the selection of GIST patients who may qualify for imatinib mesylate therapy within the context of the patient's clinical history, tumor morphology, and other diagnostic tests evaluated by a qualified pathologist. The test is not intended as the sole basis for making the diagnosis of GIST and is not intended as the sole basis for selecting imatinib mesylate therapy. A negative result would not necessarily exclude the diagnosis of GIST
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: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code NKF

FDA records hold no clearances under product code NKF.

Recent recalls

Product code NKF

Z-0115-04Increased level of non-specific or background staining.Ventana Medical Systems Inc / initiated 2003-04-04 / 95

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About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)