海利生物(603718.SH):尿液多項質控品獲得醫療器械註冊證
格隆匯1月17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質控品;主要組成成分:免疫球蛋白G、轉鐵蛋白、α1-微球蛋白、β2-微球蛋白、視黃醇結合蛋白、尿微量白蛋白、肌酐、N-乙酰-β-D-氨基葡萄糖苷酶、PBS緩衝液、氯化鈉、表面活性劑、保護劑、穩定劑;預期用途:本產品為尿液多項質控品,包含項目為免疫球蛋白G、轉鐵蛋白、α1-微球蛋白、β2-微球蛋白、視黃醇結合蛋白、尿微量白蛋白、肌酐、N-乙酰-β-D-氨基葡萄糖苷酶,與捷門生物生產的相應試劑配套使用。
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同類尿液多項質控品的醫療器械註冊證書。例如,上海科華生物工程股份有限公司、德國西門子醫學診斷產品有限公司、羅氏診斷產品(上海)有限公司有同類產品。
尿液多項質控品可通過測量已知質控範圍的質控物,來檢驗試劑盒的有效性,液體劑型,並提供多種規格,方便醫療機構進行室內質量控制。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。該產品的上市進一步豐富了捷門生物檢測試劑的種類,有利於滿足不同的市場需求,對公司未來發展具有積極作用,但短期對業績不會產生重大影響。
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