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可孚醫療(301087.SZ):5項產品取得醫療器械註冊證
格隆匯 12-15 20:02

格隆匯12月15日丨可孚醫療(301087.SZ)公佈,公司於近日收到湖南省藥品監督管理局頒發的5項《醫療器械註冊證》,具體情況如下:

1.尿酸測試儀,本產品與配套的尿酸試紙配合使用,用於體外定量檢測人體毛細血管全血或靜脈全血中的尿酸濃度。本產品可由專業人士或高尿酸血癥患者在家中或在醫療單位進行尿酸濃度監測,臨牀上主要用於高尿酸血癥的輔助診斷。

2.尿酸試紙,本產品用於體外定量檢測人體毛細血管全血或靜脈全血中的尿酸濃度。本產品可由專業人士或高尿酸血癥患者在家中或在醫療單位進行尿酸濃度監測,臨牀上主要用於高尿酸血癥的輔助診斷。

3.尿酸質控液,與本公司生產的尿酸測試儀及尿酸試紙配合使用,用於尿酸檢測的質量控制。

4.葡萄糖質控液,與本公司生產的血糖儀及血糖試紙配合使用,用於血糖檢測的質量控制。

5.人絨毛膜促性腺激素(HCG)檢測試劑盒(膠體金法),本產品用於人尿液中人絨毛膜促性腺激素(HCG)的定性檢測。

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