Standard No.:	YY/T 1261-2015
English Name:	Detection kit for analysis of HER2 gene abnormalities(fluorescent in situ hybridization )
Chinese Name:	HER2基因检测试剂盒（荧光原位杂交法）
Chinese Classification:	44
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2015-03-02
Implemented on:	2016-1-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	130.0
Delivery:	via email in 1~3 business day

本标准规定了HER2基因检测试剂盒（荧光原位杂交法）的定义、试验方法、标识、标签、使用说明书、包装、运输和贮存等要求。
本标准适用于由HER2基因位点及17号染色体着丝粒荧光原位杂交探针和复染剂组成，通过检测样本（通常是乳腺癌组织切片）上HER2基因位点的异常情况，从而辅助判断与HER2基因相关的肿瘤（如：乳腺癌等）并在治疗过程中指导临床用药的试剂盒。