PMI

Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

产品代码: PMI
器械名称: Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement
管理类别: 第 3 类（Class III）
FDA 专业组: Unknown
上市路径: HDE - Humanitarian Device Exemption

FDA 分类定义

A fluorescence in situ hybridization (FISH) assay for PDGFRB rearrangement is a qualitative in vitro diagnostic assay to detect large rearrangements or translocations within the PDGFRB gene locus. It is indicated as an aid in the assessment of patients for whom treatment with tyrosine kinase inhibitors might be appropriate.

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）。

FDA 官方分类页： PMI

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。