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海利生物(603718.SH):子公司α2-巨球蛋白測定試劑盒(膠乳免疫比濁法)獲得醫療器械註冊證
格隆匯 02-22 16:40

格隆匯2月22日丨海利生物(603718.SH)公佈,公司全資子公司上海捷門生物技術有限公司(簡稱“捷門生物”)相關產品於近日收到上海市藥品監督管理局頒發的《醫療器械註冊證》(體外診斷試劑)。

產品名稱:α2-巨球蛋白測定試劑盒(膠乳免疫比濁法)。預期用途:供醫療機構用於體外測定人尿液樣本中α2-巨球蛋白的含量,作輔助診斷用。

根據國家藥品監督管理局官方網站數據查詢信息,截至公吿日國內外同行業有部分廠家已取得α2-巨球蛋白測定試劑盒的醫療器械註冊證書。例如,北京九強生物技術股份有限公司、德國西門子醫學診斷產品有限公司、貝克曼庫爾特(美國)股份有限公司等有同類產品。

近年來,公司致力於“動保+人保”的雙輪驅動戰略,正在形成“雙主業”共同發展格局,尤其深耕人用體外診斷試劑(IVD)領域的產品和技術。此次獲證的α2-巨球蛋白測定試劑盒(膠乳免疫比濁法)用於體外測定人尿液樣本中α2-巨球蛋白的含量。α2-巨球蛋白在尿液樣本中的出現與增高情況,可以反映腎小球病變程度,通常用於臨牀醫院及醫學檢驗中心為腎臟的早期損害提供有價值的輔助診斷。捷門生物生產的上述測定試劑盒,可以測定人尿液樣本,試劑盒包含校準品和質控品,方便客户定標和質量控制。

該產品取得註冊證後,無須再履行其他審批程序即可上市銷售。

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