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邁克生物(300463.SZ):新冠抗原自測產品獲得澳大利亞TGA註冊
格隆匯 03-10 18:37

格隆匯3月10日丨邁克生物(300463.SZ)公佈,公司的新冠病毒抗原自測產品於近日獲得澳大利亞藥品管理局(簡稱“澳大利亞TGA”)的醫療用品註冊。

產品名稱:Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) AntigenAssay Kit by Colloidal Gold Method(中文譯名:新型冠狀病毒抗原試劑盒(膠體金法));預期用途:該產品用於通過人鼻拭子樣本對新型冠狀病毒(SARS-CoV-2)的核衣殼蛋白(N蛋白)抗原進行定性檢測,輔助評估新型冠狀病毒感染狀況和臨牀診斷,適用於個人及居家自我檢測。

公司新冠抗原自測產品獲得澳大利亞TGA註冊後,可在澳大利亞和認可澳大利亞TGA註冊的國家與地區進行銷售,公司新冠病毒檢測全面解決方案實現了全應用場景覆蓋,有利於提升公司新冠檢測產品的國際競爭力,為全球疫情防控提供更多助力。

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