临床化学体外诊断试剂分析性能评估要点探讨  

Overview of the Evaluation Points for In Vitro Diagnostic Reagents of Clinical Chemistry

作　　者：崔涛[1] 陈洪忠[1] 张云娟[1] 

机构地区：[1]山东省食品药品监督管理局审评认证中心,山东济南250000

出　　处：《生物技术通讯》2017年第3期356-359,共4页Letters in Biotechnology

摘　　要：根据国家及地方食品药品监督部门的政策法规要求和作者从事体外诊断试剂产品审评工作的经验,阐述临床化学体外诊断试剂分析性能评估研究要点,为此类产品的研发和申报提供指导性建议。According to the policies and regulations of the state food and drug supervision and administration department and my experience of in vitro diagnostic products technical review, the evaluation points of clinical chemistry kits were discussed, to provide recommendations for products development and research and registration declaration of such reagents.

关 键 词：临床化学 检测 体外诊断试剂 

分 类 号：R197[医药卫生—卫生事业管理]