普门科技(688389.SH):H100Plus血红蛋白检测系统获得美国FDA 510(k)准入

智通财经
Oct 08

智通财经APP讯,普门科技(688389.SH)发布公告,近日,公司收到美国食品药品监督管理局(简称“FDA”)的通知,公司H100Plus血红蛋白检测系统获得美国FDA 510(k)准入。该产品用于体外定量检测人全血中糖化血红蛋白(HbA1c)的含量,可辅助糖尿病诊断。该产品获得美国FDA 510(k)准入,表明公司H100Plus血红蛋白检测系统符合FDA的相关要求,具备美国市场的准入资格,有利于进一步提升公司产品开拓海外市场的综合竞争力。

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