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明德生物(002932.SZ):新冠病毒抗原檢測試劑取得醫療器械註冊證
格隆匯 03-16 11:47

格隆匯3月16日丨明德生物(002932.SZ)公佈,近日,公司研製的新型冠狀病毒(2019-nCoV)抗原檢測試劑盒(膠體金法)取得國家藥品監督管理局頒發的《醫療器械註冊證》。

該產品用於體外定性檢測鼻拭子/鼻咽拭子/口咽拭子樣本中新型冠狀病毒(2019-nCoV)N抗原。適用人羣參照《新型病毒抗原檢測應用方案(試行)》等國家相關規定執行。該產品不能單獨用於新型冠狀病毒感染的診斷,陽性結果僅表明樣本中可能存在新型冠狀病毒特定抗原,應結合核酸檢測結果判斷感染狀態。陰性結果不能排除新型冠狀病毒感染,也不得單獨作為作出治療和疾病管理決定的依據。有相應臨牀症狀的疑似患者抗原檢測不管是陽性還是陰性,均應進行進一步的核酸檢測。檢測陽性受試者應遵循當地疫情防控政策進行報吿和隔離,並尋求相應的醫療幫助;檢測陰性受試者應嚴格遵守當地疫情防控要求,必要時採用核酸檢測進行確認。

公司表示,公司新型冠狀病毒(2019-nCoV)抗原檢測試劑盒(膠體金法)在國內獲批上市,豐富了公司產品線,提高了公司在相關領域的核心競爭力,對公司未來的經營發展將產生正面影響。

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