DZ/T 0101.12-1994
Active
YY/T 1890-2023
Active
Industry standards-Medicine
YY/T 1890-2023 Hepatitis B virus surface antigen (HBsAg) detection kit(Immunochromatographic method)
YY/T 1890-2023 Hepatitis B virus surface antigen (HBsAg) detection kit(Immunochromatographic method)
Basic Information
Standard Code:
YY/T 1890-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2023-09-05
Implement Date:
2024-09-15
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
本文件规定了乙型肝炎病毒表面抗原检测试剂盒(免疫层析法)的要求、试验方法、标识、标签和使用说明、包装、运输和贮存等。
本文件适用于采用胶体金法、乳胶法等免疫层析法，对人血清、血浆或全血中的乙型肝炎病毒表面抗原(以下简称HBsAg)进行定性检测的乙型肝炎病毒表面抗原检测试剂盒。
本文件不适用于采用酶联免疫法、化学发光免疫法、时间分辨免疫荧光法等方法的乙型肝炎病毒表面抗原检测试剂盒。
Development Information
Drafting Units:
中国食品药品检定研究院、北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、广东省医疗器械质量监督检验所、北京万泰生物药业股份有限公司、珠海丽珠试剂股份有限公司、英科新创(厦门)科技股份有限公司
Drafting Persons:
刘艳、李克坚、周诚、刘艳春、潘晓芳、鲜阳凌、周昕、秦荣
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 29791.1-2013 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 191-2025 Graphical symbols marking for handling and storage of packages
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