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萬泰生物(603392.SH):新冠病毒核酸檢測試劑盒(PCR-熒光探針法)獲美國FDA緊急使用授權
格隆匯 09-10 17:26

格隆匯9月10日丨萬泰生物(603392.SH)公佈,公司的新型冠狀病毒(2019-nCoV)核酸檢測試劑盒(PCR-熒光探針法)(英文名稱Wantai SARS-CoV-2RT-PCRKit)於近日獲得美國食品藥品監督管理局(英文全稱“Food And Drug Administration”,以下簡稱“FDA”)簽發的緊急使用授權(簡稱“EUA”,英文全稱“Emergency Use Authorization”)。

該產品之前已經獲得歐盟CE認證,並加入世界衞生組織(WHO)緊急使用清單(EUL)。本次獲得美國FDA緊急使用授權後,此產品可在美國市場或在其他接受美國FDA緊急授權使用的國家銷售,對公司銷售及國際業務拓展具有積極的作用。

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