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萬泰生物(603392.SH):公司相關檢測產品獲得美國FDA緊急使用授權
格隆匯 08-07 16:08

格隆匯 8 月 7日丨萬泰生物(603392.SH)公佈,公司的新型冠狀病毒抗體檢測試劑盒(酶聯免疫法)(英文名稱WANTAI SARS-CoV-2 Ab ELISA)於美國時間202086日獲得美國食品藥品監督管理局(英文全稱“Food And Drug Administration”,FDA”)簽發的緊急使用授權(“EUA”,英文全稱“Emergency Use Authorization”)。

公司本次獲得FDA簽發的EUA授權的新型冠狀病毒抗體檢測試劑盒(酶聯免疫法)用於定性檢測人血清和血漿(枸櫞酸葡萄糖,ACD)中新冠病毒的總抗體(包括IgGIgM抗體)WANTAI SARS-CoV-2 Ab ELISA旨在用於識別對新冠病毒具有相應免疫反應的個人,提示最近或之前的感染。

此次獲得美國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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