DZ/T 0101.12-1994
Active
YY/T 1882-2023
Active
Industry standards-Medicine
YY/T 1882-2023 Treponema pallidum antibodies detection kit(Luminescence immunoassay)
YY/T 1882-2023 Treponema pallidum antibodies detection kit(Luminescence immunoassay)
Basic Information
Standard Code:
YY/T 1882-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2023-03-14
Implement Date:
2024-11-01
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:
12 pages
Scope
本文件规定了梅毒螺旋体抗体检测试剂盒（发光免疫分析法)的要求、试验方法、标识、标签和使用说明书、包装、运输和储存。
本标准适用于以夹心法或间接法为基本原理，使用化学发光免疫分析法、免疫荧光分析法、时间分辨免疫荧光分析法定性检测人血清和/或血浆中的梅毒螺旋体抗体。
Development Information
Drafting Units:
中国食品药品检定研究院、郑州安图生物工程股份有限公司、科美诊断技术股份有限公司、雅培贸易(上海)有限公司、罗氏诊断产品(上海)有限公司、希森美康医用电子(上海)有限公司、深圳市新产业生物医学工程股份有限公司
Drafting Persons:
夏德菊、王新明、王建梅、吴晓军、蔡晓蓉、苏静、袁锦云
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
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