YY/T 0456.1-2003
Replaced
YY/T 1213-2019
Active
Industry standards-Medicine
YY/T 1213-2019 Follicle stimulating hormone testing kit
YY/T 1213-2019 Follicle stimulating hormone testing kit
Basic Information
Standard Code:
YY/T 1213-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2019-05-31
Implement Date:
2020-06-01
Publisher:
国家药品监督管理局
Technical Committee:
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)
Pages:
8 pages
Scope
本标准规定了促卵泡生成素测定试剂盒的分类、要求、试验方法、标签和使用说明书、包装、运输、贮存。
本标准适用于以双抗体夹心法为原理定量测定促卵泡生成素的试剂盒，包括以酶标记、（电）化学发光标记、（时间分辨）荧光标记等标记方法的免疫分析试剂盒。
本标准不适用于：用胶体金或其他方法标记的半定量测定促卵泡生成素的试剂（如：试纸条等）；用125I等放射性同位素标记的各类促卵泡生成素放射免疫或免疫放射试剂盒。
Development Information
Drafting Units:
中国食品药品检定研究院、北京市医疗器械检验所、罗氏诊断产品(上海)有限公司、西门子医学诊断产品(上海)有限公司、雅培贸易(上海)有限公司、奥森多器械贸易(中国)有限公司、博奥生物集团有限公司
Drafting Persons:
黄颖、于婷、曲守方、孙楠、黄杰、王瑞霞、蔡晓蓉、葛亚文、汪少颖、肖璐、王雪峰、吴晓军、施为红、郭健夫
Replace the following standards
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
Related Standards
YY/T 0456.2-2003
Replaced
YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin
YY/T 0456.3-2003
Replaced
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0475-2004
Replaced
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0478-2004
Replaced
YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active