摘要
白蛋白作为常见的检测项目,用于检测人体样本中的白蛋白含量,临床上用于评价肝脏功能及营养评估。文章从体外诊断试剂审评的角度出发,参照《体外诊断试剂注册与备案管理办法》、YY/T 1228-2014《白蛋白测定试剂(盒)》、指导原则等标准对此类产品进行注册要点讨论分析,以期为注册申请人在该类产品申报时提供技术参考。
As a common test item,albumin is used to detect the albumin content in human samples,and is clinically used to evaluate liver function and nutritional assessment.From the perspective of in vitro diagnostic reagent review,this paper discusses and analyzes the key points of registration of such products with reference to the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents,YY/T 1228-2014 Albumin Determination Reagents(Boxes),guidelines and other standards,in order to provide technical reference for registration applicants when applying for such products.
作者
陈雨萱
张瑜
杨葳
CHEN Yu-xuan;ZHANG Yu;YANG Wei(Binhai Office of Tianjin Center for Medical Devices Evaluation and Inspection,Tianjin 300110;Tianjin Center for Medical Devices Evaluation and Inspection,Tianjin 300110)
出处
《中国医疗器械信息》
2025年第9期14-17,共4页
China Medical Device Information
关键词
白蛋白测定试剂
体外诊断试剂
审评要点
albumin assay reagents
in vitro diagnostic reagents
key points of evaluation
