美康生物(300439.SZ)子公司獲兩項醫療器械註冊證
格隆匯6月2日丨美康生物(300439.SZ)公佈,公司全資子公司美康盛德醫療科技(蘇州)有限公司於近日取得由江蘇省藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》,產品分別為“全自動尿液有形成分分析儀”及“基質輔助激光解吸電離飛行時間質譜儀”。
全自動尿液有形成分分析儀用於自動化模擬顯微鏡操作技術流程,對尿液中的有形成分進行影像分析鑑別,包括自動分類(鑑定)指標:紅細胞,白細胞,鱗狀上皮細胞,透明管型,病理管型,細菌,非鱗狀上皮細胞,精子,白細胞團,粘液絲,酵母菌,未分類結晶;手工分類(鑑定)指標:草酸鈣結晶、尿酸結晶、三磷酸鹽結晶、碳酸鈣結晶、磷酸鈣結晶、無定形結晶、胱氨酸結晶、亮氨酸結晶、酪氨酸結晶、紅細胞管型、顆粒管型、白細胞管型、細胞管型、上皮細胞管型、蠟樣管型、脂肪管型、寬管型、腎臟上皮細胞、過渡上皮細胞、假菌絲、紅細胞團、滴蟲、橢圓形脂肪體、脂肪。
基質輔助激光解吸電離飛行時間質譜儀採用基質輔助激光解吸電離飛行時間(MALDI-TOF)質譜技術對細菌及真菌進行鑑定。
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