Standard No.:	YY/T 1182-2010
English Name:	Nucleic acids amplification test reagents(kits)
Chinese Name:	核酸扩增检测用试剂（盒）
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Issued by:	China Food and Drug Administration
Issued on:	2010-12-27
Implemented on:	2012-6-1
Status:	superseded
Superseded by:	YY/T 1182-2020 Nucleic acids amplification test reagents(kits)
Superseded on:	2021-1-1
Language:	English
File Format:	PDF
Word Count:	7000 words
Price(USD):	210.00
Delivery:	via email in 1~3 business day

本标准规定了核酸扩增检测试剂(盒)的术语和定义、命名和分类、技术要求、试验方法、标识、标签和说明书、包装、运输和贮存等。
本标准适用于核酸扩增检测试剂(盒)的质量控制。核酸扩增检测试剂(盒)应包括核酸提取、核酸扩增及产物分析试剂组份,如核酸扩增检测试剂(盒)内不含有核酸提取组份,应由生产企业说明或指定提取试剂(盒)。
本标准不适用于基因分型、基因芯片和病毒基因分型/突变检测用试剂(盒)及血源筛查的试剂(盒)。