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Immunoturbidimetry reagent (kit)
Standard in brief
Scope of Application:
本标准规定了免疫比浊法检测试剂(盒)(透射法)的术语和定义、要求和试验方法、标识、标签和使用说明书、包装、运输和贮存等。
本标准适用于基于透射免疫比浊原理,在半自动、全自动生化分析仪或其他类型的分析仪上进行定量检测的试剂(盒)。
Basic information
Standard No:YY/T 1255-2015
Standard Name:免疫比浊法检测试剂(盒)(透射法)
English Name:Immunoturbidimetry reagent (kit)
Standard Status:现行
Release Date:2015-03-02
Effective Date:2016-01-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.100
CCS Number:C44
Related Standards
Referenced Standards:GB/T 21415
Publication Information
Number of pages:12
Number of words:14 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2015-06-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家食品药品监督管理总局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:1255
Drafter:毕春雷、吴杰、康娟、张艳、陈其云、田伟
Drafting Organization:北京市医疗器械检验所、上海复星长征医学科学有限公司、贝克曼库尔特实验系统(苏州)有限公司、四川迈克生物科技股份有限公司、罗氏诊断产品(上海)有限公司
Management Organization:全国医用临床检验实验室、体外诊断系统标准化技术委员会(SAC/TC 136)
Proposing Department:国家食品药品监督管理总局