九安医疗：美国子公司三联检产品和新冠检测产品获得美国FDA应急使用授权及上市前通知
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九安医疗：美国子公司三联检产品和新冠检测产品获得美国FDA应急使用授权及上市前通知
证券时报e公司讯，九安医疗(002432)6月2日晚间通知布告，公司美国子公司iHealth美国的以下产物取得了美国食物药品监视治理局（FDA）的审核授权：1.新型冠状病毒、甲型流感病毒及乙型流感病毒三联检测（POC）试剂盒取得应急利用授权（EUA）。该产物取得美国应急利用授权（EUA）后，可在美国公共卫生健康应急时代，在美国和承认美国EUA的国度/地域发卖。2.新型冠状病毒家庭检测（OTC）试剂盒收到美国FDA510(K)上市前通知。该产物可在美国和承认该授权许可的国度/地域正常发卖。 .app-kaihu-qr {text-align: center;padding: 20px 0;} .app-kaihu-qr span {font-size: 18px; line-height: 31px;display: block;} .app-kaihu-qr img {width: 170px;height: 170px;display: block;margin: 0 auto;margin-top: 10px;} 股市回暖，抄底炒股先开户！智能定投、前提单、个股雷达……送给你>>。
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