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萬孚生物(300482.SZ):核酸擴增分析系統獲註冊批准
格隆匯 09-09 12:10

格隆匯9月9日丨萬孚生物(300482.SZ)宣佈,公司的核酸擴增分析系統於近日獲國家藥品監督管理局審批通過。註冊證號為“國械注準20203220724”,有效期至2025年8月31日。

目前,傳統的熒光PCR檢測需要專業PCR認證的實驗操作人員和專業認證的PCR實驗室環境,且檢測時間較長,無法為臨牀提供靈活快速的檢測結果。

公司的核酸擴增分析系統可以在一個封閉的試劑卡盒裏面完成全部步驟,降低PCR污染,實現從樣本到結果的一體化檢測,操作快速簡便,可大幅提高各級醫療機構的檢測工作效率,幫助臨牀醫生縮短選擇適當抗生素的時間,快速診斷以阻止不必要的抗生素使用,改善抗生素使用方式,對抗細菌耐藥及抗生素濫用。

公司表示,公司核酸擴增分析系統的獲批,填補了國內在核酸提取、擴增、雜交一體機方面的空白,對公司未來的經營將產生積極影響。

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