Standard No.:	YY/T 1916-2023
English Name:	Interleukin-6(IL-6) testing kit(labelling immunoassay)
Chinese Name:	白介素6（IL-6）测定试剂盒（标记免疫分析法）
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2023-09-05
Implemented on:	2024-9-15
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	165.0
Delivery:	via email in 1~3 business day

本文件规定了白介素6测定试剂盒（标记免疫分析法）的要求、试验方法及标识、标签和使用说明书、包装、运输和贮存等要求。
本文件适用于以标记免疫为反应原理定量测定人血清、血浆或全血中IL-6含量的试剂盒，方法学包含荧光标记免疫层析法、化学发光法等。
本文件不适用于对IL-6校准品和质控品的评价。