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陕西省医疗器械质量监督检验院 >> 信息动态 >> 公告通知 >> 正文
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陕西省医疗器械质量监督检验院 >>公告通知 >> 正文
miR-92a检测试剂盒(荧光RT-PCR法)获批上市
作者: 信息来源:转载自国家总局网站 点击数:811 更新时间:2018/3/30 4:06:14

  近日,国家食品药品监督管理总局经审查,批准了深圳市晋百慧生物有限公司生产的创新产品 “miR-92a检测试剂盒(荧光RT-PCR法)”的注册。

  该产品采用RNA提取试剂盒提取粪便中的RNA,进行RT-PCR反应。miR-92a对于大肠癌的辅助检测是一个新的标志物,且得到了较为广泛的认可,产品样本采集方便,不会对患者造成痛苦及不适,于大肠癌的辅助诊断提供了一种较为方便的方法,可以较快的提供检测结果以指导医生对患者的诊治,对于高危人群同时由于不同原因拒绝进行肠镜检查患者的大肠癌临床辅助诊断具有较高的应用价值。

  食品药品监管部门鼓励支持医疗器械产业创新发展,进一步做好创新医疗器械审查,加强产品上市后质量监管,保障公众用械安全,确保医疗器械产业的健康有序发展。

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