QDI

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

产品代码

QDI

器械名称

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 864.1880

FDA 专业组

Medical Genetics

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)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

Fluorescence In Situ Hybridization (FISH) Test for Hematologic Malignancies is used to detect chromosomal abnormalities in human specimens from patients with hematologic malignancies. The test is indicated for the clinical management of patients consistent with World Health Organization (WHO) guidelines and in conjunction with other clinical and diagnostic criteria. The results are to be interpreted by a pathologist or equivalent professional.

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）。