亞輝龍(688575.SH):全自動化學發光免疫分析儀(iFlash3000-M、iFlash3000-N)取得醫療器械註冊證
格隆匯11月24日丨亞輝龍(688575.SH)公佈,公司於近日收到了由廣東省藥品監督管理局簽發的醫療器械註冊證,具體信息如下:
產品名稱及規格:全自動化學發光免疫分析儀(iFlash3000-M、iFlash3000-N);預期用途:採用基於吖啶酯的直接化學發光法,與配套的檢測試劑共同使用,在臨牀上用於對來源於人體的血清、血漿、尿液樣本中的被分析物進行定性或定量檢測,包括維生素、激素、心肌疾並感染性疾並自身抗體、腫瘤相關抗原、蛋白質及多肽類、肝並免疫功能項目。
本次拿證的 iFlash3000-M、iFlash3000-N規格全自動化學發光免疫分析儀,進一步豐富了公司的全自動化學發光儀器,iFlash3000-M、iFlash3000-N儀器體積小巧,檢測速度高達120測試/小時,可滿足中、低測試量實驗室更高效率、更低成本的需求。
截至目前,公司已有多款全自動化學發光免疫分析儀取得醫療器械註冊證,包括單機測試速度高達600測試/小時、模塊聯機後整機測試速度最高可達到2400測試/小時的高速全自動化學發光免疫分析儀;單機測試速度達到300測試/小時、模塊聯機後整機測試速度最高可達到1200測試/小時的大型化學發光測定儀;測試速度180測試/小時的中小型全自動化學發光免疫分析儀;測試速度120測試/小時的小型全自動化學發光免疫分析儀;單人份的POCT全自動化學發光測定儀,能夠滿足不同診斷數量的用户需求。
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