DZ/T 0101.12-1994
Active
YY/T 1786-2024
Active
Industry standards-Medicine
YY/T 1786-2024 Hepatitis B e antigen (HBeAg) detection kit(chemiluminescent immunoassay)
YY/T 1786-2024 Hepatitis B e antigen (HBeAg) detection kit(chemiluminescent immunoassay)
Basic Information
Standard Code:
YY/T 1786-2024
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2024-07-08
Implement Date:
2025-07-20
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
本文件规定了乙型肝炎病毒e抗原检测试剂盒（化学发光免疫分析法）的技术要求、标识、标签、使用说明书、包装、运输和贮存等，描述了相应的试验方法。本文件适用于利用化学发光免疫分析技术，测定人血清、血浆中乙型肝炎病毒e抗原的试剂盒（以下简称“试剂盒”）。包括化学发光、微粒子化学发光、电化学发光、光激化学发光和时间分辨荧光等方法。本文件不适用于：a) 拟用于单独销售的乙型肝炎病毒e抗原校准品和乙型肝炎病毒e抗原质控品；b) 以化学发光免疫分析为原理的生物芯片。
Development Information
Drafting Units:
中国食品药品检定研究院、雅培贸易(上海)有限公司、郑州安图生物工程股份有限公司、广州市达瑞生物技术股份有限公司、北京万泰生物药业股份有限公司、科美诊断技术股份有限公司
Drafting Persons:
李克坚、周诚、王雪峰、张利红、吴英松、王洪兰、王建梅
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 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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