Standard No.:	YY/T 1586-2018
English Name:	Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR)
Chinese Name:	肿瘤个体化治疗相关基因突变检测试剂盒（荧光PCR法）
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2018-02-24
Implemented on:	2019-3-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	3000 words
Translation Price(USD):	90.0
Delivery:	via email in 1~3 business day

本标准规定了肿瘤个体化治疗相关基因突变检测试剂盒的要求、试验方法及标签、使用说明书、包装、运输和贮存等内容。
本标准适用于肿瘤个体化治疗相关基因突变实时荧光PCR方法的核酸检测技术。本标准所指的基因突变类型包括碱基置换、颠换、插入、缺失等。