迪瑞醫療(300396.SZ)獲得1項醫療器械註冊證
格隆匯10月19日丨迪瑞醫療(300396.SZ)宣佈,公司於近日取得由國家藥品監督管理局頒發的1項《醫療器械註冊證》。產品名稱為“腫瘤標誌物質控品Ⅱ”;註冊證編號為“國械注準20203400773”;註冊證有效期為2020年9月27日至2025年9月26日;分類為Ⅲ類。
臨牀用途為用於對公司生產的胃蛋白酶原Ⅰ測定試劑盒、胃蛋白酶原Ⅱ測定試劑盒、人附睾蛋白4測定試劑盒、蛋白質Sangtec-100測定試劑盒、異常凝血酶原測定試劑盒、癌抗原72-4測定試劑盒、神經元特異性烯醇化酶測定試劑盒、細胞角質蛋白19片段測定試劑盒、鱗狀上皮細胞。
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,公司化學發光免疫分析檢測試劑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。
公司表示,上述化學發光免疫分析產品的取得,進一步豐富了公司產品種類,增強公司綜合競爭力,有利於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。
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