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華大基因(300676.SZ):三項新型冠狀病毒檢測產品延續註冊
格隆匯 01-14 20:13

格隆匯 1 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)三項新型冠狀病毒檢測產品2020126通過了國家藥品監督管理局(以下簡稱國家藥監局)應急審批程,獲得了藥監局頒發醫療器械註冊證具體內容詳見公司於202023日披露的關於全資子公司取得醫療器械註冊證的公吿》(吿編號:2020-006)

近日,公司已按照國家藥監局的相關要求,完成了上述三項產品的延續註冊取得了相應的醫療器械證書註冊證具體信息如下

新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR)是一款基於RT-PCR技術的快速檢測試劑盒;新型冠狀病毒2019-nCoV核酸檢測試劑盒(合探針錨定聚合測序法)則是基於宏基因組測序檢測試劑盒結合RT-PCR宏基因組測序兩個檢測方法,可更快、更全面覆蓋2019-nCoV病毒檢測,並監測新型冠狀病毒在傳播過程中可能會發生的變異。

上述檢測產品延續註冊有利於維持新型冠狀病毒核酸檢測試劑供給能力,實現對新型冠狀病毒炎疑似病例、聚集性病例、其他需要進行新型冠狀病感染診斷或鑑別診斷者進行更快、更全面的檢測,全力協助疫情防控機構開展新型冠狀病毒感染的檢測工作,服務疫情防控需要。

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