華大基因(300676.SZ):控股子公司取得醫療器械註冊證
格隆匯3月25日丨華大基因(300676.SZ)公佈,公司控股子公司北京華大吉比愛生物技術有限公司近日取得北京市藥品監督管理局頒發的醫療器械註冊證,產品名稱為抗甲狀腺球蛋白抗體(TG-Ab)測定試劑盒(化學發光免疫分析法)。
抗甲狀腺球蛋白抗體(TG-Ab)測定試劑盒(化學發光免疫分析法)用於體外定量測定人血清中抗甲狀腺球蛋白抗體(TG-Ab)的含量,測定結果可以為輔助人體自身免疫性甲狀腺疾病的診斷、療效觀察及愈後評估提供重要依據。該產品在技術方面較為成熟,在國內外人體甲狀腺功能檢測市場已有較為廣泛的使用。根據國家藥品監督管理局官網數據查詢信息,截至公告披露日,國內外同行業已有多個廠家取得上述產品的醫療器械註冊證。
上述《醫療器械註冊證》的取得,進一步豐富和完善了公司精準醫學綜合解決方案業務產品線,是對公司現有甲狀腺功能檢測產品的有效補充,有助於進一步提升公司業務的核心競爭力,不斷滿足市場需求,對公司未來的業務發展將產生積極影響。
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