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U.S. Department of Health and Human Services

Product Classification

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Device immunohistochemistry antibody assay, c-kit
Regulation Description Immunohistochemistry reagents and kits.
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 Medical Specialty Hematology
Review Panel Pathology
Product CodeNKF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Regulation Number 864.1860
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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