新產業(300832.SZ):公司新冠檢測產品獲得美國FDA緊急使用授權
格隆匯 9 月 15日丨新產業(300832.SZ)宣佈,近日,公司的新型冠狀病毒化學發光試劑盒獲得美國食品藥品監督管理局(英文全稱“U.S.FoodAndDrugAdministration”,以下簡稱“FDA”)簽發的緊急使用授權(英文全稱“EmergencyUseAuthorization”,以下簡稱“EUA”)。

本次獲授產品是根據美國《新型冠狀病毒肺炎在公共危機下的診斷檢測政策指南》獲得的在公共危機下新型冠狀病毒抗體檢測產品正式進入美國臨牀市場銷售的資質,是產品的臨時使用,如果在緊急情況終止後,則需另行向美國FDA提交產品註冊申請。
鑑於目前美國新型冠狀病毒疫情發展的不確定性,上述產品實際銷售情況取決於美國市場對新冠抗體檢測的需求量以及公司在美國市場拓展情況,公司目前尚無法預測其對公司未來業績的影響,敬請投資者注意投資風險。
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