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海利生物(603718.SH):全資子公司產品尿液多項校準品獲得醫療器械註冊證
格隆匯 02-07 16:44

格隆匯2月7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(以下簡稱“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),產品名稱為尿液多項校準品。

主要組成成分:重組蛋白(β2-微球蛋白、α1-微球蛋白、視黃醇結合蛋白)、高值原料(尿微量白蛋白、轉鐵蛋白、免疫球蛋白G)、PBS緩衝液、氯化鈉、表面活性劑、保護劑、穩定劑。預期用途:該產品配套捷門生物生產的β2-微球蛋白、α1-微球蛋白、視黃醇結合蛋白、尿微量白蛋白、轉鐵蛋白、免疫球蛋白G測定試劑盒使用,用於定量測定人尿液樣本中β2-微球蛋白、α1-微球蛋白、視黃醇結合蛋白、尿微量白蛋白、轉鐵蛋白、免疫球蛋白G時的校準。

產品儲存條件及有效期:2~8℃避光儲存,有效期2年。

截至目前,該產品累計已發生的研發投入約為21萬元。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同類尿液多項校準品的醫療器械註冊證書。例如,德國西門子醫學診斷產品有限公司、羅氏診斷產品(上海)有限公司等有同類產品。

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