迪瑞醫療(300396.SZ):16項醫療器械產品取得CE認證證書
格隆匯2月17日丨迪瑞醫療(300396.SZ)公佈,公司的16項醫療器械產品於近日取得了CE認證證書,產品名稱包括性激素結合球蛋白測定試劑盒(化學發光免疫分析法)、妊娠相關血漿蛋白A測定試劑盒(化學發光免疫分析法)、醛固酮測定試劑盒(化學發光免疫分析法)、全段甲狀旁腺激素測定試劑盒(化學發光免疫分析法)、降鈣素測定試劑盒(化學發光免疫分析法)、抗繆勒管激素測定試劑盒(化學發光免疫分析法)、β2-微球蛋白測定試劑盒(化學發光免疫分析法)、胰島素抗體測定試劑盒(化學發光免疫分析法)、17α-羥孕酮測定試劑盒(化學發光免疫分析法)、硫酸脱氫表雄酮測定試劑盒(化學發光免疫分析法)、白介素-6測定試劑盒(化學發光免疫分析法)、25-羥基維生素D測定試劑盒(化學發光免疫分析法)、尿液理化分析用複合校準物、尿液理化分析用複合質控物、尿液幹化學分析質控物、乳酸測定試劑盒(乳酸氧化酶法)。
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、心臟標誌物等。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。
尿液分析技術目前在國內外已經成為臨牀檢驗項目的常規檢測技術,隨着國內廠商技術不斷進步,與國外尿液分析產品的差距不斷縮小,公司在尿液分析領域多年來積累了較強的產品、品牌優勢和技術儲備。
生化診斷是最早實現自動化的檢測手段,也是目前最常用的體外診斷方法之一。我國的體外診斷產業經過三十多年來的發展,已經形成了一定的規模並且與臨牀的需求基本相適應。目前,醫療衞生機構是消費生化試劑產品的主力軍。
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,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際市場的銷售,為廣大股東創造更大的價值。
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