医疗器械优先审批申请审核结果公示（2024年第16号）20241128
发布时间：2024-11-28
依据原国家食品药品监督管理总局《医疗器械优先审批程序》（总局公告2016年168号），对申请优先审批的医疗器械注册申请进行审核，现将符合优先审批情形的项目予以公示，公示时间为2024年11月28日至12月5日。
|
序号 |
受理号 |
产品名称 |
申请人 |
同意理由 |
|
1 |
CSZ2400451 |
人类免疫缺陷病毒1+2型尿液抗体检测试剂盒（胶体金法） |
北京万泰生物药业股份有限公司 |
该产品属于“列入国家科技重大专项的医疗器械”。 |
公示期内，任何单位和个人如有异议，可填写医疗器械优先审批项目异议表，提交至我中心电子邮箱：gcdivision@cmde.org.cn。
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2024年11月28日
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