好货分享：26份体外诊断技术审评报告
医疗器械技术审评报告是申请人在产品申报医疗器械注册时提交的书面报告，此报告为审评中心审评时提供依据，相对而言公开的医疗器械技术审评报告也为其他申请人提供指导。截至目前，医疗器械技术审评中心已公开72份医疗器械产品技术审评报告，涉及体外诊断的有26份，报告内容分为基本信息、产品审评摘要、综合评价意见三大类，清单如下。总共12个附件，全部下载下来，解压缩就可以了
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif1.RNF180Septin9基因甲基化检测试剂盒（PCR荧光探针法）（CSZ1900136）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif2.遗传性耳聋基因检测试剂盒（联合探针锚定聚合测序法）（CSZ1900042）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif3.人EGFR-KRAS-BRAF-HER2-ALK-ROS1基因突变检测试剂盒（半导体测序法）（CSZ1900047）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif4.结核分枝杆菌特异性细胞因子检测试剂盒 （酶联免疫法）（CSZ1700172）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif5.核酸扩增检测分析仪（CQZ1900342）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif6.结核分枝杆菌复合群核酸检测试剂盒（恒温扩增-实时荧光法）（CSZ1900160）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif7.结核分枝杆菌特异性细胞免疫反应检测试剂盒（酶联免疫法）（CSZ1900135）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif8.胚胎植入前染色体非整倍体检测试剂盒（半导体测序法）（CSZ1900093）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif10.水通道蛋白抗体（AQP4 Ab）检测试剂盒（酶联免疫法）（JSZ1800016）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif12.无创血糖仪（CQZ1900180）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif9.PD-L1检测试剂盒（免疫组织化学法）（JSZ1800126）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif14.结核分枝杆菌复合群核酸检测试剂盒（恒温扩增荧光法）（CSZ1700171）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif13.PD-L1检测试剂盒（免疫组织化学法）（JSZ1800077）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif16.人类10基因突变联合检测试剂盒（可逆末端终止测序法）（CSZ1700127）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif15.人类SDC2基因甲基化检测试剂盒（荧光PCR法）（CSZ1800035）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif18.全自动化学发光免疫分析仪（CQZ1700087）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif17.EGFR、ALK、ROS1、BRAF、KRAS、HER2基因突变检测试剂盒（可逆末端终止测序法）（CSZ1800026）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif11.甲型-乙型流感及呼吸道合胞病毒核酸联合检测试剂盒（实时荧光PCR法）（JSZ1800082）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif19.人EGFR、KRAS、BRAF、PIK3CA、ALK、ROS1基因突变检测试剂盒（半导体测序法）（CSZ1700089）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif22.miR-92a检测试剂盒（荧光RT-PCR法）（CSZ1600116）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif20.人EGFR-ALK-BRAF-KRAS基因突变联合检测试剂盒（可逆末端终止测序法）（CSZ1700157）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif23.风疹病毒IgG抗体检测试剂（荧光免疫层析法）（CSZ1700071）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif21.丙型肝炎病毒核酸测定试剂盒（PCR-荧光探针法）（CSZ1700055）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif24.麻疹病毒IgG抗体检测试剂（荧光免疫层析法）（CSZ1700073）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif25.人类EGFR突变基因检测试剂盒(多重荧光PCR法)(CSZ1700057）.pdf
https://mmbiz.qlogo.cn/mmbiz_png/cYWEUSQJ5HAORuJke3gGOgGEHdJ5uwxUDwpQ2Xuicz5lkRmT1GL7RjqosFwiaic2ibaNWK0gHPUic9sz30Swodichiaxg/0?wx_fmt=gif26.基因测序仪（CQZ1700334）.pdf------------------------------------------------------------------------------End
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