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萬孚生物(300482.SZ):三款新型冠狀病毒檢測產品獲得歐盟CE認證
格隆匯 03-06 16:52

格隆匯3月6日丨萬孚生物(300482.SZ)公佈,近日,公司的三款新型冠狀病毒檢測產品取得了歐盟頒發的CE認證。

產品名稱1:2019-nCoV新型冠狀病毒抗體檢測試劑(免疫層析法);用於體外快速、定性檢測人血清、血漿和全血樣本中新型冠狀病毒(2019-nCoV)IgG/IgM抗體,有助於由新型冠狀病毒(COVID-19)感染引起的疾病的輔助檢查。

產品名稱2:2019-nCoV新型冠狀病毒IgM抗體檢測試劑(熒光免疫層析法);產品名稱3:2019-nCoV新型冠狀病毒抗體檢測試劑(熒光免疫層析法);均用於定性檢測人血清、血漿和全血樣本中新型冠狀病毒(2019-nCoV)抗體,有助於由新型冠狀病毒(COVID-19)感染引起的疾病的輔助檢查。

上述新型冠狀病毒的抗體檢測產品為新冠肺炎的疑似患者、無症狀患者、密切接觸者,核酸檢測陰性者提供快速、便捷的現場檢測手段,協助疾控部門和醫療機構等採取及時有效的防控措施,較好地滿足各國疫情現場快速檢測防控需求,在全球範圍內助力新型冠狀病毒感染的新冠疫情防控工作。

上述產品取得CE認證,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,對公司未來的經營將產生積極影響。

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