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華大基因(300676.SZ)對新冠抗原檢測產品醫療器械註冊證進行了變更
格隆匯 03-13 17:10

格隆匯3月13日丨華大基因(300676.SZ)公佈,公司控股子公司深圳華大因源醫藥科技有限公司於近日取得國家藥品監督管理局頒發的《中華人民共和國醫療器械註冊變更文件(體外診斷試劑)》,對新冠抗原檢測產品的醫療器械註冊證進行了變更。

本次華大因源新冠抗原檢測產品醫療器械註冊證的變更主要系根據《新冠病毒抗原檢測應用方案(試行)》等國家相關規定,對產品預期用途、説明書、儲存條件及產品有效期進行了變更。

抗原檢測是直接針對病毒中的特有蛋白質(即抗原)進行檢測,能夠在急性感染期快速檢出陽性病例,可以用於特定人羣篩查的補充檢測手段,有利於提高“早發現”能力,對優化新冠病毒檢測策略和整體疫情防控具有重要作用。

上述獲證產品需與乾式熒光免疫分析儀適配使用,檢測結果穩定性高、特異性好,並具備自動判讀檢測結果和信息化管理檢測樣本的優勢。

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