聖湘生物(688289.SH):新冠(SARS-CoV-2)快速抗原檢測試劑盒(免疫層析法)獲得歐盟CE認證
格隆匯4月13日丨聖湘生物(688289.SH)公佈,公司的產品新型冠狀病毒(SARS-CoV-2)快速抗原檢測試劑盒(免疫層析法)於近日獲得歐盟CE認證。
應用領域:定性檢測人鼻拭子樣本中SARS-CoV-2抗原(Ag)核衣殼蛋白,用於居家使用。預期用途:本產品是一次性使用、肉眼判斷的快速免疫檢測試劑,適用於對疑似有COVID-19症狀的人鼻拭子樣本中SARS-CoV-2抗原(Ag)核衣殼蛋白的定性檢測。本試劑被授權用於17歲或以上的人居家檢測使用,17歲以下的兒童應由成人幫助採集和測試。
本次公司獲CE認證的新型冠狀病毒(SARS-CoV-2)快速抗原檢測試劑盒(免疫層析法)運用免疫層析技術,可在較短時間內檢測人鼻拭子樣本中SARS-CoV-2抗原(Ag)核衣殼蛋白,並肉眼完成結果判讀,簡單方便,無需儀器,適用於多種場景的快速檢測需求。
公司以上產品獲得歐盟CE認證後,可在歐盟國家和認可歐盟CE認證的國家銷售。上述產品可滿足疫情居家檢測防控需求,由此,公司海外銷售產品品類得到進一步擴充,對公司銷售及國際業務拓展具有積極的作用。
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