艾德生物(300685.SZ):收到醫療器械變更註冊文件
格隆匯1月27日丨艾德生物(300685.SZ)公佈,公司近日收到由國家藥監局頒發的《醫療器械變更註冊文件》,公司完成“人類BRCA1基因和BRCA2基因突變檢測試劑盒(可逆末端終止測序法)”產品原註冊證相關事項的變更。變更內容:預期用途增加“本產品可用於卵巢癌患者進行帕米帕利膠囊治療的用藥指導”。
公司表示,上述《醫療器械註冊證》的變更,有利於進一步提升公司在婦科及內分泌腫瘤精準診療領域的競爭力,對公司未來經營將產生積極影響。
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