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                          日本一乙肝检测试剂盒一年内不予在中国注册

                          2015-02-28 13:05:02

                          JIZHE28RICONGGUOJIASHIPINYAOPINJIANGUANZONGJUHUOXI,YINFAXIANRIBENFUSHIRUIBIOUZHUSHIHUISHEDEYIXINGGANYANBINGDUHEXINXIANGGUANKANGYUANJIANCESHIJIHEDELINCHUANGSHIYANSHUJUCUNZAIZHENSHIXINGDENGWENTI,SHIYAOJIANZONGJUJUEDINGDUIGAIZHUCESHENQINGBUYUZHUCE,QIEYINIANNEIBUZAISHOULI。

                          不思棋牌SHIYAOJIANZONGJUZHICHU,JINGJIANDUJIANCHA,FAXIANGAICHANPINZHUCESHENQINGCUNZAIQIYERENYUANBIANZAOCUNDANGZILIAO,SHIYANSHUJUBUNENGSUYUAN,YANJIUBAOGAOZHONGMIAOSHUDEYANGBENBINGZHONGYUSHIJIBUFUDENGWENTI。

                          JUXI,ZAIGAICHANPINDELINCHUANGYANJIUZONGBAOGAOZHONG,MINGQUEJIXINGYIXINGGANYANYANGBENGONGRUXUAN40LI。SHANGHAISHIGONGGONGWEISHENGLINCHUANGZHONGXINYANJIUBAOGAOZHONGYANGBENWEI9LI,CHOUCHAQIZHONG5LI,LINCHUANGZHENDUANJUNWEIFEIJIXINGYIXINGGANYAN;BEIJINGYOUANYIYUANYANJIUBAOGAOZHONGYANGBENWEI12LI,JINGHEDUISHIYANJIGOUHISXITONG,QIZHONG9LIBIAOZHUDEZHENDUANNEIRONGWEIFEIJIXINGYIXINGGANYAN;JIEFANGJUNDISANLINGERYIYUANYANJIUBAOGAOZHONGYANGBENWEI19LI,JINGHEDUISHIYANJIGOULISXITONG,QIZHONG1LIWEIFEIJIXINGYIXINGGANYANYANGBEN。

                          此外,研究报告中描述的样本冻存期也与实际不符。报告中描述的是样本采集后在-20°C冻存不超过一个月或-80°C冻存不超过6个月,但在上海市公共卫生临床中心和北京佑安医院抽查发现的样本冻存时间均超过6个月。

                          对此,食药监总局表示,根据《体外诊断试剂注册管理办法》“注册申报资料虚假的”规定,对该申请人的乙型肝炎病毒核心相关抗原检测试剂盒注册申请不予注册。对该注册申请自不予注册之日起一年内不予再次受理。

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