随着我国检验医学的发展,诊断试剂是一个多学科、多品种、更新更快的高技术应用产品,在临床实验室工作中,起着愈来愈重要的作用。长期以来,诊断试剂某些产品需要按药品管理,部分血液筛查试剂甚至要批批检,而一大部分诊断试剂没有明确的分类和管理办法。随着国家对医药行业改革 With the development of the laboratory medicine in our country, the diagnostic reagent is a multidisciplinary, multi-species, newer and faster high-tech application product, which plays more and more important role in clinical laboratory work. For a long time, certain products of diagnostic reagents need to be managed by drugs. Some blood screening reagents even need to be approved. Most of the diagnostic reagents do not have a clear classification and management. With the national reform of the pharmaceutical industry