邁克生物(300463.SZ):兩個新產品獲得產品註冊證書
格隆匯1月20日丨邁克生物(300463.SZ)公佈,公司全資子公司邁克醫療電子有限公司(“邁克醫療”)於近日收到四川省藥品監督管理局頒發的《醫療器械註冊證》,產品名稱包括全自動血細胞分析儀;全自動化學發光免疫分析儀。
此次獲得註冊證書的全自動血細胞分析儀F800(“F800”)為公司血液檢測平台的新產品,血常規每小時檢測速度為100測試,並帶有網織紅細胞檢測等特殊項目,F800與公司已經上市銷售的全自動血細胞分析儀F580、F560組成血液檢測系列化產品;此次獲得註冊證書的全自動化學發光免疫分析儀i1000(“i1000”)為公司直接化學發光平台新增的中低速產品,每小時檢測速度180測試,其配套試劑與公司已上市銷售的全自動化學發光免疫分析儀i3000(“i3000”)通用,新產品i1000、i3000單機、i3000聯機及已經發布的免疫流水線形成了直接化學發光產品平台系列化。
上述兩個產品獲得註冊證書均促進其產品平台完成系列化,可滿足不同客户羣體以及不同應用場景的需求,將進一步鞏固公司在血液檢測和化學發光免疫檢測領域的競爭優勢,同時,公司綜合競爭力與市場拓展能力也將得到提升,對公司未來的經營將產生積極影響。
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