DZ/T 0101.12-1994
Active
YY/T 1880-2022
Active
Industry standards-Medicine
YY/T 1880-2022 Serum amyloid A testing kit
YY/T 1880-2022 Serum amyloid A testing kit
Basic Information
Standard Code:
YY/T 1880-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2022-10-17
Implement Date:
2023-10-01
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
本文件规定了血清淀粉样蛋白A 测定试剂盒的通用技术要求，包括要求、试验方法、标签和使用说明书、包装、运输和贮存。
本文件适用于以抗原-抗体免疫反应为基本原理的定量测定人源样本中的血清淀粉样蛋白A 的试剂盒，包括免疫比浊法、免疫层析法和化学发光免疫分析法试剂盒。
本文件不适用于胶体金免疫层析法定量试剂盒。
Development Information
Drafting Units:
北京市医疗器械检验研究院、上海奥普生物医药股份有限公司、浙江省医疗器械审评中心、北京九强生物技术股份有限公司、中生北控生物科技股份有限公司、重庆医疗器械质量检验中心、广州万孚生物技术股份有限公司
Drafting Persons:
李胜民、王鼎、何蕊、王晓建、韩瑜、何乐春、孙雅玲、陈微
Referenced Standards
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 29791.2-2013 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
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