DZ/T 0101.12-1994
Active
YY/T 1256-2024
Active
Industry standards-Medicine
YY/T 1256-2024 Ureaplasma nucleic acid detection kit
YY/T 1256-2024 Ureaplasma nucleic acid detection kit
Basic Information
Standard Code:
YY/T 1256-2024
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2024-02-07
Implement Date:
2025-03-01
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:
16 pages
Scope
本文件规定了解脲脲原体核酸检测试剂盒的分类、技术要求、标签、使用说明书、包装、运输和贮存，描述了相应的试验方法。本文件适用于检测人泌尿道、生殖道和呼吸道脲原体的核酸检测试剂盒（以下简称试剂盒)，采用的方法学有荧光PCR法、恒温扩增法、PCR膜杂交法。
Development Information
Drafting Units:
中国食品药品检定研究院、河南省药品医疗器械检验院、重庆医疗器械质量检验中心、安徽安兰智控生物科技有限公司、北京万泰生物药业股份有限公司
Drafting Persons:
沈舒、刘东来、王玉梅、张娟丽、罗文广、季磊、鲜阳凌
Replace the following standards
Referenced Standards
GB/T 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements
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 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials
GB/T 21415-2025 In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators,trueness control materials and human samples
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