Immunohistochemistry Antibody Assay, C-Kit
- US Product Code (FDA)
- NKFView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 864.1860View CFR Regulation →
- Medical specialty
- Hematology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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
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Immunohistochemistry Antibody Assay, C-Kit is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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