迪瑞醫療(300396.SZ):1項化學發光領域產品完成註冊變更
格隆匯2月2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1項《醫療器械變更註冊(備案)文件》。涉及產品名稱:糖類抗原50測定試劑盒(化學發光免疫分析法);分類:Ⅲ。
主要變更內容包括:1、產品適用儀器的變更:全自動化學發光免疫分析儀(型號:CM-180、CM-320、CM-320i)、模塊化生化免疫分析系統(型號:CSM-8000)。變更為迪瑞全自動化學發光免疫分析儀(型號:CM-180、CM-320、CM-320i、CM-640、CM-640i)、迪瑞模塊化生化免疫分析系統(型號:CSM-8000、CSM-9000);2、產品説明書變更。
上述涉及化學發光領域產品的變更註冊,豐富了公司產品種類,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。
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