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基蛋生物(603387.SH):部分醫療器械產品延續註冊、變更登記及新取得醫療器械註冊證
格隆匯 03-03 18:57

格隆匯3月3日丨基蛋生物(603387.SH)公佈,公司於近日收到由江蘇省藥品監督管理局頒發1醫療器械註冊具體情況如下:

公司於近日收到江蘇省藥品監督管理頒發的《醫療器械註冊變更文件(體外診斷試劑)具體情況如下:

公司近日收到了由江蘇省藥品監督管理局頒發的《醫療器械註冊證》和國家藥品監督管理局頒發的《醫療器械註冊證(體外診斷試劑)具體情況如下

截至20191231日,生化免疫定量分析儀累計已發生的研發投入約2039.85萬元。癌胚抗原檢測試劑盒累計已發生的研發投入約93.98萬元。

根據國家藥品監督管理局官網數據查詢信息:截至公告日國內外同行業多個廠家已取得同類產品的醫療器械註冊證書。強生、富士等具有乾式生化產品,市場上暫無同時支持幹化學分析法乾式免疫熒光法兩種檢測方法的自動化儀器癌胚抗原檢測試劑盒國內註冊證34個,酶聯免疫2個,熒光2個,比濁2個,時間分辨1個,化學發光27個;進口註冊證12個。

上述《醫療器械註冊證》的延續註冊,將能保障產品的持續銷售,延續了公司在體外診斷領域的持續競爭力,對公司未來經營將產生積極影響。

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