迪安診斷(300244.SZ):新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)取得醫療器械註冊證
格隆匯 3 月 23日丨迪安診斷(300244.SZ)公佈,近日,公司全資子公司杭州迪安生物科技有限公司研製的新型冠狀病毒檢測產品通過國家藥品監督管理局審批,並獲得醫療器械註冊證。
產品名稱為新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法);預期用途:本試劑盒用於體外定性檢測新型冠狀病毒肺炎疑似病例、聚集性病例、其他需要進行新型冠狀病毒感染診斷或鑑別診斷者的咽拭子、痰液樣本中,新型冠狀病毒(2019-nCoV)0RFlab基因、N基因。
上述《醫療器械註冊證》有效期五年,豐富了公司自有產品種類,將增強公司的核心競爭力,有利於公司拓展國內外市場,公司將全力做好新型冠狀病毒疫情防控物資的生產供應,積極履行社會責任。
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