新產業(300832.SZ)獲得2項醫療器械註冊證
格隆匯12月17日丨新產業(300832.SZ)宣佈,近日,公司收到廣東省藥品監督管理局頒發的2項《醫療器械註冊證》。
其中,“N-乙酰-β-D氨基葡萄糖苷酶測定試劑盒(MPT底物法)”註冊分類為Ⅱ類;試劑盒用於體外定量測定人尿液或血清中N-乙酰-β-D-氨基葡萄糖苷酶(NAG)的活性濃度,臨牀上主要用於輔助評價腎小管損害。
“遊離脂肪酸測定試劑盒(ACS-ACOD法)”註冊分類為Ⅱ類;該試劑用於體外定量測定人血清或血漿中游離脂肪酸(NEFA)的含量。臨牀上主要用於高脂血症、冠心病和動脈粥樣硬化的輔助診斷。
截至目前,公司已先後取得57項生化試劑《醫療器械註冊證》。以上新產品醫療器械註冊證的取得,豐富了公司生化檢測產品中“腎功能”、“脂類”項目類別,將對公司發展具有正面影響。
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