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迪安診斷(300244.SZ):三款新型冠狀病毒檢測產品獲英國MHRA註冊
格隆匯 03-25 19:33

格隆匯3月25日丨迪安診斷(300244.SZ)公佈,公司全資子公司杭州迪安生物科技有限公司(“迪安生物”)的三款新型冠狀病毒檢測產品於近日獲得了英國Medicines & Healthcare products Regulatory Agency(簡稱:“MHRA”;中文譯名:英國藥品和健康產品管理局)的註冊(註冊號:IVD001122)。產品名稱為新冠核酸檢測試劑盒,新冠核酸提取試劑盒及新冠核酸提取儀。預期用途:適用於新型冠狀病毒感染的肺炎疑似患者或其他需要進行新型冠狀病毒感染診斷或鑑別診斷者,通過檢測從受檢者採集的咽拭子等樣本中提取的核酸以確定受檢者是否有新型冠狀病毒感染。

上述新型冠狀病毒的檢測產品為新冠肺炎的疑似患者、無症狀患者、密切接觸者提供檢測,協助疾控部門和醫療機構等採取及時有效的防控措施,助力新型冠狀病毒感染的新冠疫情防控工作。

迪安生物上述產品獲得英國MHRA註冊,表明該系列產品符合歐盟相關要求,已經具備歐盟市場的准入條件,將進一步增強公司產品的綜合競爭力,為全球新冠肺炎疫情防控貢獻力量

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