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Immunohistochemistry kit
Standard in brief
Scope of Application:
本标准规定了免疫组织化学试剂盒通用的产品分类、要求、试验方法及标识、标签、使用说明书、包装、运输和贮存等内容。本标准适用于基于抗原抗体反应,用于检测人体组织及细胞样本等的组织化学/细胞化学定性试剂或试剂盒。
Basic information
Standard No:YY/T 1181-2021
Standard Name:免疫组织化学试剂盒
English Name:Immunohistochemistry kit
Standard Status:现行
Release Date:2010-12-27
Effective Date:2023-03-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.100.10
CCS Number:C44
Related Standards
Referenced Standards:GB/T 191,GB/T 29791.2
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:2021-10-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家药品监督管理局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:1181
Drafter:毕春雷、杨清海、刘佳、袁钧、郭金灿、王东、孙楠
Drafting Organization:北京市医疗器械检验所、福州迈新生物技术开发有限公司、安捷伦科技(中国)有限公司、罗氏诊断产品(上海)有限公司、厦门通灵生物医药科技有限公司、基因(科技)上海股份有限公司、中国食品药品检定研究院
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:国家药品监督管理局