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海利生物(603718.SH):全資子公司二類醫療器械註冊申請獲得受理
格隆匯 03-30 16:25

格隆匯3月30日丨海利生物(603718.SH)宣佈,公司全資子公司捷門生物相關產品向上海市藥品監督管理局提交了二類醫療器械產品擬上市註冊的行政許可申請,並於2021年3月29日收到上海市藥品監督管理局下發的《行政許可受理通知書》。

產品名稱:C-反應蛋白-血清澱粉樣蛋白A二聯測定試劑盒(熒光免疫層析法),受理號:21-071;產品名稱:血清澱粉樣蛋白A測定試劑盒(熒光免疫層析法),受理號:21-073。

C-反應蛋白-血清澱粉樣蛋白A二聯測定試劑盒(熒光免疫層析法)用於體外測定人血清、血漿、全血樣本中血清澱粉樣蛋白A、C-反應蛋白的含量。血清澱粉樣蛋白A和C反應蛋白都是由肝臟產生的急性時相蛋白,C-反應蛋白用於感染性疾病的初篩已在很多醫院普及。而血清澱粉樣蛋白A比C-反應蛋白反應更靈敏,兩者聯合檢測可以更有效的提高感染性疾病的檢出率,同時兩者的組合也可用於細菌和病毒感染的診斷和鑑別,為臨牀醫生提供更敏感的診斷依據。

血清澱粉樣蛋白A測定試劑盒(熒光免疫層析法)用於體外測定人血清、血漿、全血樣本中血清澱粉樣蛋白A的含量。血清澱粉樣蛋白A是急性期蛋白,在炎症、感染性和非感染性疾病期間,它在血液中的濃度能在數小時內急劇升高,可升高到最初濃度的1000倍。可用於慢性炎症疾病、動脈粥樣硬化、糖尿病腎病、急性心肌梗死、冠心病、慢性腎臟疾病等的臨牀早期輔助診斷。

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