九安醫療(002432.SZ):美國子公司三聯檢產品和新冠檢測產品獲得美國FDA應急使用授權及上市前通知
格隆匯6月2日丨九安醫療(002432.SZ)發佈公吿,公司於北京時間2024年6月1日凌晨獲悉,公司美國子公司 iHealth Labs Inc.(以下簡稱“iHealth 美國”)的以下產品獲得了美國食品藥品監督管理局(FDA)的審核授權:
1.新型冠狀病毒、甲型流感病毒及乙型流感病毒三聯檢測(POC)試劑盒獲得應急使用授權(EUA)。該產品獲得美國應急使用授權(EUA)後,可在美國公共衞生健康應急期間,在美國和認可美國EUA的國家/地區銷售。
2.新型冠狀病毒家庭檢測(OTC)試劑盒收到美國FDA 510(K)上市前通知。該產品可在美國和認可該授權許可的國家/地區正常銷售。
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