NKF

Immunohistochemistry Antibody Assay, C-Kit

产品代码

NKF

器械名称

Immunohistochemistry Antibody Assay, C-Kit

管理类别

第 3 类（Class III）

21 CFR 条款

21 CFR 864.1860

FDA 专业组

Hematology

上市路径

需 PMA 上市前批准

FDA 分类定义

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

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。