Standard No.:	YY/T 1216-2020
English Name:	Alpha-fetoprotein testing kit
Chinese Name:	甲胎蛋白测定试剂盒
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2020-06-30
Implemented on:	2021-6-1
Status:	valid
Superseding:	YY/T 1216-2013 Alpha-fetoprotein quantitative labelling immunoassay kit
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	120.0
Delivery:	via email in 1~3 business day

本标准规定了甲胎蛋白标记免疫测定试剂产品的分类、要求、检验方法、标示、标签、使用说明书、包装、运输和贮存等。本标准适用于以标记免疫测定为原理检测人血液基质或其它体液成分中的甲胎蛋白（AFP）定量测定试剂，包括以酶、化学发光、荧光物等方法标记捕获抗体，以微孔板、管、磁颗粒、微珠和塑料珠、微流控芯片、纳米材料等为载体包被抗体定量测定AFP的免疫测定试剂盒。本标准不适用于：胶体金标记AFP试纸条；用125I等放射性同位素标记的各类放射免疫。