迪瑞醫療(300396.SZ):申報醫療器械註冊獲受理
格隆匯5月19日丨迪瑞醫療(300396.SZ)公佈,公司於近日取得由吉林省藥品監督管理局頒發的2項《受理通知書》,產品名稱為遊離β人絨毛膜促性腺激素測定試劑盒(化學發光免疫分析法);抗凝血酶Ⅲ測定試劑盒(髮色底物法)。
遊離β人絨毛膜促性腺激素測定試劑盒屬於化學發光免疫分析產品,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。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,再添產業新佈局。
抗凝血酶Ⅲ測定試劑盒屬於凝血產品,當今出血和血栓性疾病患者數量持續增加,對疾病的監管要求也越來越高。隨着科學技術的日新月異,血栓與止血檢測從傳統的手工方法發展到全自動凝血分析,從單一的凝固法發展到免疫學和生物化學法,血栓與止血的檢測變得更加簡便、準確、精確。利用凝血分析進行止血與血栓的實驗室檢查,可以為出血性和血栓性疾病的診斷與鑑別診斷、溶栓及抗凝治療的監測與療效觀察提供有價值的指標。
上述產品目前所處的審批階段為:註冊申請受理,後續所需的審批流程為技術審評、行政審批、制證。上述品種註冊申請受理對公司近期業績不會產生影響,審評在各階段所需的時間和結果均具有一定的不確定性,公司將對上述品種的後續進展情況及時履行信息披露義務。
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