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Chinese Standard: YY/T 1304.1-2015

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Detection system of time-resolved fluoroimmunoassay—Part 1:Semi-auto time-resolved fluoroimmunoassay analyser


Standard in brief
Scope of Application:  
YY/T 1304的本部分规定了半自动时间分辨荧光免疫分析仪(以下简称分析仪)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。
本部分适用于单标记时间分辨荧光免疫分析。
本部分不适用于双标记及多标记时间分辨荧光免疫分析。

Basic information
Standard No:YY/T 1304.1-2015
Standard Name:时间分辨荧光免疫检测系统 第1部分:半自动时间分辨荧光免疫分析仪
English Name:Detection system of time-resolved fluoroimmunoassay—Part 1:Semi-auto time-resolved fluoroimmunoassay analyser
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 4793.1,GB/T 14710,GB/T 18268.1,GB/T 18268.26,YY 0648

Publication Information
Number of pages:12
Number of words:12 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2015-09-01

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:1304.1
Drafter:张新梅、吴英松、黄哲锋、杜海鸥
Drafting Organization:北京市医疗器械检验所、广州市达瑞抗体工程技术有限公司、苏州新波生物技术有限公司
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

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