諾唯贊(688105.SH):新型冠狀病毒抗原檢測試劑取得醫療器械註冊證
格隆匯3月11日丨諾唯贊(688105.SH)公佈,公司全資子公司南京諾唯贊醫療科技有限公司(“諾唯贊醫療”)自主研發生產的新型冠狀病毒抗原檢測試劑盒於近日收到國家藥品監督管理局頒發的《醫療器械註冊證》(注冊證編號:國械注準 20223400346)。
公司上述新型冠狀病毒抗原檢測試劑盒可用於檢測新型冠狀病毒感染疑似人羣口咽拭子、鼻咽拭子樣本中新型冠狀病毒N抗原和S抗原。上述產品一般用於急性感染期,即疑似人羣出現症狀7天之內的樣本檢測,可作為核酸檢測的輔助和補充,配合國家新型冠狀病毒檢測策略,進一步提高“早發現”能力。
新型冠狀病毒感染的確認應結合核酸檢測、影像學等其他診斷信息及病史、接觸史判斷感染狀態。公司上述新型冠狀病毒抗原檢測試劑盒不可單獨用於新型冠狀病毒感染的診斷,應由經專業培訓的人員在確保生物安全和滿足使用條件的環境下使用。
此次新型冠狀病毒抗原檢測試劑產品國內獲批上市,進一步豐富了公司新型冠狀病毒檢測整體解決方案的應用場景,有助於提升公司在相關領域的競爭力,可更好地助力我國新冠疫情防控工作。上述產品的實際銷售情況受新冠疫情變化、防控政策及檢測需求等多因素影響,公司尚無法預測該產品的獲批對未來業績的具體影響。
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