YY/T 0456.1-2003
Replaced
YY/T 1811-2022
Active
Industry standards-Medicine
YY/T 1811-2022 Complement 4 testing kit (immunoturbidimetric method)
YY/T 1811-2022 Complement 4 testing kit (immunoturbidimetric method)
Basic Information
Standard Code:
YY/T 1811-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2022-05-18
Implement Date:
2023-06-01
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:
12 pages
Scope
本文件规定了补体4测定试剂盒（免疫比浊法）的要求、试验方法及标识、标签和使用说明书、包装、运输和贮存。本文件适用于免疫比浊法（免疫透射比浊法和免疫散射比浊法）对人血清或血浆中的补体4进行定量检测的试剂盒，包括在半自动、全自动生化分析仪或特定蛋白分析仪上使用的试剂盒。
Development Information
Drafting Units:
重庆医疗器械质量检验中心、重庆中元汇吉生物技术有限公司、北京利德曼生化股份有限公司、罗氏诊断产品(上海)有限公司、山东博科生物产业有限公司
Drafting Persons:
何乐春、易维京、任轶昆、赖留恋、谢清华
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 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 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 21415-2025 In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators,trueness control materials and human samples
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