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Chinese Standard: YY/T 1448-2016

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Lipoprotein(a) test reagent


Standard in brief
Scope of Application:  
本标准规定了脂蛋白(a)测定试剂盒的要求、试验方法、标识、标签和使用说明书、包装、运输和贮存等要求。
本标准适用于使用免疫比浊法(透射法)对人血清或血浆中的脂蛋白(a)进行定量检测的试剂盒,包括手工试剂和在半自动、全自动生化分析仪上使用的试剂。

Basic information
Standard No:YY/T 1448-2016
Standard Name:脂蛋白(a)测定试剂盒
English Name:Lipoprotein(a) test reagent
Standard Status:现行
Release Date:2016-01-26
Effective Date:2017-01-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.110
CCS Number:C44

Related Standards
Referenced Standards:YY/T 0466.1

Publication Information
Number of pages:12
Number of words:16 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2017-01-01

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:1448
Drafter:毕春雷、黄妍、刘炳忠、王蕴峰、龙腾镶、杜海鸥
Drafting Organization:北京市医疗器械检验所、北京九强生物技术股份有限公司、北京利德曼生化股份有限公司、中生北控生物科技股份有限公司、四川迈克科技生物股份有限公司
Management Organization:全国医用临床检验实验室和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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