摘要
目的进一步规范我国体外诊断试剂液体辅助试剂分类和命名原则。方法根据《体外诊断试剂注册管理办法(试行)》等有关法规,以及既往分类界定文件和这类产品分类界定申请的有关情况,对体外诊断试剂液体辅助试剂的类别、分类界定情况进行梳理。结果与结论将现有体外诊断试剂液体辅助试剂分为:清洗液、反应物质溶解液、反应物质稀释液、样本预处理液、样本保存溶液、缓冲液、染色液及其封闭剂、显色液、第二抗体溶液等9小类,对这些产品的风险程度管理和规范命名提出意见和建议。
Objective To further standardize the classification and nomenclature of the liquid auxiliary reagent （LAR） in vitro diagnostics （IVDs）. Methods The current classification of LAR was analyzed and summarized according to the IVDs relevant laws, regulations issued by SFDA and former classification application. Results and Conclusion The LAR products were classified into nine categories： washing liquid, reacting substance solution, reacting substance diluent, sample pretreatment solution, sample preserving fluid, buffer solution, dying liquor and its inclusion reagent, colour developing reagent, second antibody solution, etc.. Some suggestions were accordingly proposed on the classification by the risk degree and the standardized nomenclature of each category.
出处
《中国药事》
CAS
2013年第11期1143-1146,共4页
Chinese Pharmaceutical Affairs
关键词
体外诊断试剂
液体辅助试剂
分类界定
in vitro diagnostics （IVDs）
liquid auxiliary reagent （LAR）
classification
