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華大基因(300676.SZ):全資子公司取得醫療器械註冊證變更
格隆匯 05-14 12:31

格隆匯5月14日丨華大基因(300676.SZ)公佈,公司全資子公司華大生物科技(武漢)有限公司(以下簡稱“武漢生物科技”)於2020年1月26日取得國家藥品監督管理局(以下簡稱“國家藥監局”)頒發的新型冠狀病毒檢測相關產品的三個醫療器械註冊證。

近日武漢生物科技的上述新型冠狀病毒檢測相關產品取得國家藥監局頒發的醫療器械註冊變更文件。上述兩款新型冠狀病毒檢測試劑盒及一款分析軟件於2020年1月26日通過了國家藥監局應急審批程序,成為首批正式獲准上市的抗擊冠狀病毒疫情的檢測產品之一。

目前,為更好地適應疫情防控的需求,公司對上述產品的適用機型、預期用途、產品説明書及產品技術要求等內容進行了變更,並取得了相應的醫療器械注冊變更文件。上述新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)產品在原適用機型基礎上增加前述三款適用機型,該變更能夠滿足不同客户的新型冠狀病毒檢測需求,有利於公司提高產品的市場開拓能力和公司的綜合競爭力,更好地助力新型冠狀病毒感染的肺炎疫情防控工作。

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