迪瑞醫療(300396.SZ)獲得2項醫療器械註冊證
格隆匯2月24日丨迪瑞醫療(300396.SZ)公佈,公司於近日取得由國家藥品監督管理局頒發的2項《醫療器械註冊證》,產品名稱為神經元特異性烯醇化酶測定試劑盒(化學發光免疫分析法)、細胞角蛋白19片段測定試劑盒(化學發光免疫分析法)。
化學發光免疫分析作為體外診斷行業最重要的細分項目之一,其臨牀應用涵蓋多個病種,包括腫瘤、甲功、激素、傳染病、心肌標誌物等。化學發光免疫分析技術目前在歐美等發達國家已經成為臨牀試驗室廣泛使用的常規檢測技術。對於國內市場來説,目前化學發光檢測產品大部分為國外大廠商生產的產品,我國化學發光檢測產業還處於發展期。不過隨着國內廠商技術的不斷進步,差距在不斷縮小,近些年國內湧現出了一批較具代表性的廠家。
截止目前,公司化學發光免疫分析檢測試劑產品註冊證增至75項,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產品有CM-180及CM-320全自動化學發光免疫分析儀,其中新產品CM-320全自動化學發光免疫分析儀採用直接化學發光磁微粒技術,可多模塊進行組合,最高4模塊可達到1280測試/小時,滿足大型實驗室的需求。
上述《醫療器械註冊證》的取得,豐富了公司產品種類,將進一步增強公司綜合競爭力,有利於進一步提高公司的市場拓展能力,對公司未來的經營將產生積極影響。上述產品實際銷售情況取決於未來市場推廣效果,公司目前尚無法預測其對公司未來業績的影響,敬請投資者注意投資風險。公司未來會積極推動相關產品在國內市場的銷售,為廣大股東創造更大的價值。
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