新產業(300832.SZ):獲得2項化學發光試劑《醫療器械註冊證》
格隆匯10月21日丨新產業(300832.SZ)宣佈,近日,公司收到國家藥品監督管理局頒發的2項《醫療器械註冊證》。
其中,“胃泌素釋放肽前體測定試劑盒(化學發光免疫分析法)”註冊分類為Ⅲ類,註冊證編號為國械注準20203400781。該試劑盒用於體外定量測定人血清或血漿樣本中胃泌素釋放肽前體(ProGRP)的含量。主要用於對惡性腫瘤患者進行動態監測以輔助判斷疾病進程或治療效果,不能作為惡性腫瘤早期診斷或確認的依據,不能用於普通人羣。
“異常凝血酶原測定試劑盒(化學發光免疫分析法)”註冊分類為Ⅲ類,註冊證編號為國械注準20203400782。該試劑盒用於體外定量測定人血清中異常凝血酶原(PIVKA-Ⅱ)的含量。異常凝血酶原(PIVKA-Ⅱ)含量的測定用於對已確診肝癌患者進行動態監測以輔助判斷疾病進展或治療效果,不能作為惡性腫瘤早期診斷或確診的依據,不能用於普通人羣的腫瘤篩查。
截至目前,公司已先後取得128項化學發光試劑《醫療器械註冊證》。以上新產品醫療器械註冊證的取得,豐富了公司化學發光類產品線,增加了公司優勢項目類別腫瘤標誌物的試劑菜單,將對公司發展具有正面影響,但對近期的生產經營和業績不會產生重大影響。
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