PDO

Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

产品代码

PDO

器械名称

Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 864.1870

FDA 专业组

Hematology

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

The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. The assay results are to be interpreted by a qualified pathologist or cytogeneticist.

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）。