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迪瑞醫療(300396.SZ):7項產品獲得醫療器械註冊證
格隆匯 09-30 19:05

格隆匯9月30日丨迪瑞醫療(300396.SZ)公佈,公司於近日取得由吉林省藥品監督管理局頒發的7項《醫療器械註冊證》,具體情況如下:

1.全自動尿有形成分分析儀;全自動尿有形成分分析儀是專業人員使用的體外診斷醫療設備,可對尿液中有形成分進行定量和定性計數。

2.尿液分析試紙條;本品可對尿液中的尿膽原、膽紅素、酮體、血、蛋白質、亞硝酸鹽、白細胞、葡萄糖、比重、酸鹼度、抗壞血酸、微白蛋白、肌酐、尿鈣項目進行定性或半定量檢測。

3.尿液分析試紙條;本品可對尿液中的尿膽原、膽紅素、酮體、血、蛋白質、亞硝酸鹽、白細胞、葡萄糖、比重、酸鹼度、抗壞血酸、微白蛋白、肌酐、尿鈣項目進行定性或半定量檢測。

4.尿有形成分分析儀應用試劑盒;試劑盒由調焦液、標準液、陽性質控液、陰性質控液組成。調焦液用於儀器顯微成像系統焦面位置的確定,陰性質控液、陽性質控液和標準液用於測試過程的質量控制。

5.尿液電導率分析用校準物;用於尿液分析儀器測試電導率項目的校準。

6.尿液分析試紙條;本品可對尿液中的尿膽原、膽紅素、酮體、肌酐、血、蛋白質、微白蛋白、亞硝酸鹽、白細胞、葡萄糖、比重、酸鹼度、抗壞血酸、尿鈣進行定性或半定量檢測。7.尿液電導率分析用質控物;用於尿液分析儀器測試電導率項目的質量控制。

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