Standard No.:	YY/T 1961-2025
English Name:	Survival motor neuron gene(SMN) detection kit
Chinese Name:	运动神经元存活基因（SMN）检测试剂盒
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.100.10 11.100.10    In vitro diagnostic test systems 11.100.10
Source Content Issued by:	NMPA
Issued on:	2025-06-18
Implemented on:	2026-7-1
Status:	to be valid
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	225.0
Delivery:	via email in 1~3 business day

本文件规定了运动神经元存活基因（SMN）检测试剂盒的要求、标识、标签和使用说明以及包装、运输、贮存，描述了相应的试验方法。
本文件适用于荧光定量PCR法、PCR-荧光探针法、荧光PCR-毛细管电泳法、荧光PCR熔解曲线法建立的检测试剂盒。