Standard No.:	YY/T 1518-2017
English Name:	C-peptide quantitative labelling immunoassay kit
Chinese Name:	C-肽（C-P）定量标记免疫分析试剂盒
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2017-03-28
Implemented on:	2018-4-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	140.0
Delivery:	via email in 1~3 business day

本标准规定了C-肽测定试剂盒的质量要求、检验方法、标签和说明书以及包装、运输、贮存要求。
本标准适用于进行C-肽定量测定的标记免疫分析试剂盒。包括以酶标记、化学发光标记、时间分辨荧光标记等标记方法，以微孔板、管、磁颗粒、微珠和塑料珠等为载体，定量测定C-肽的免疫分析试剂盒。