OVQ

Chronic Lymphocytic Leukemia Fish Probe Kit

产品代码

OVQ

器械名称

Chronic Lymphocytic Leukemia Fish Probe Kit

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.6040

FDA 专业组

Immunology

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 历史累计 510(k)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information.

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）。