迪瑞醫療(300396.SZ):3項醫療器械產品取得CE認證證書
格隆匯 1 月 28日丨迪瑞醫療(300396.SZ)公佈,公司的3項醫療器械產品於近日取得了CE認證證書,產品名稱分別為超敏C反應蛋白測定試劑盒(化學發光免疫分析法)、血清澱粉樣蛋白A測定試劑盒(化學發光免疫分析法)、環孢黴素測定試劑盒(化學發光免疫分析法)。
化學發光免疫分析是體外診斷行業最重要的細分項目之一,公司目前發光產品可以進行甲狀腺功能、傳染病、性激素、骨代謝、炎症、腫瘤標誌物、糖代謝、心肌標誌物、腎功能、高血壓、肝纖維化、貧血等項目的檢測。公司化學發光免疫分析儀器可以滿足不同規模的終端需求。目前,公司化學發光免疫分析試劑相關產品註冊證擁有近90項,是國內體外診斷行業化學發光檢測項目較為齊全的廠家之一。在未來發展中,公司將繼續開發補充臨牀高價值檢驗項目,持續豐富體外診斷產品覆蓋領域,助力公司快速發展。
上述產品取得CE認證證書,表明了該產品符合歐盟相關要求,已經具備歐盟市場的准入條件,將進一步增強公司產品的綜合競爭力,對公司未來的經營將產生積極影響。
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