萬泰生物(603392.SH):新冠檢測產品獲得美國FDA緊急使用授權
格隆匯 7 月 13日丨萬泰生物(603392.SH)公佈,公司的新型冠狀病毒抗體快速檢測試劑盒(膠體金法)(英文名稱WANTAI SARS-CoV-2 Ab Rapid Test)於美國時間2020年07月10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快速檢測試劑盒(膠體金法)用於定性檢測人血清、血漿(K2EDTA、肝素鋰和檸檬酸鈉)和靜脈全血中新冠病毒的總抗體(包括IgG和IgM抗體)。WANTAI SARS-CoV-2 Ab快速檢測試劑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。
該產品之前已經獲得歐盟CE認證、澳大利亞TGA認證等國際重要發達經濟體的准入。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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