萬孚生物(300482.SZ)抗原檢測試劑盒收到國家藥監局頒發的醫療器械註冊變更文件
格隆匯3月13日丨萬孚生物(300482.SZ)公佈,公司於近日收到國家藥品監督管理局頒發的1項《醫療器械註冊變更文件》。產品名稱為新型冠狀病毒(2019-nCoV)抗原檢測試劑盒(膠體金法)。
本產品用於體外定性檢測口咽拭子、鼻咽拭子、鼻拭子樣本中新型冠狀病毒N抗原,增加了鼻拭子樣本的採樣方式。適用人羣參照《新冠病毒抗原檢測應用方案(試行)》等國家相關規定執行。
國務院應對新型冠狀病毒肺炎疫情聯防聯控機制綜合組決定推進“抗原篩查、核酸診斷”的監測模式,在核酸檢測基礎上,增加抗原檢測作為補充,抗原檢測試劑的鼻拭子採樣方式,拓展了應用場景,有利於提高“早發現”能力。公司將嚴格按照中央有關部門部署,秉承“不讓生命等候”的理念,有力有序為抗疫提供最大支持,以快速檢測技術更好地守護每一份健康。
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