邁克生物(300463.SZ):實時熒光定量PCR分析儀獲得產品註冊證書
格隆匯3月17日丨邁克生物(300463.SZ)公佈,公司全資子公司邁克醫療電子有限公司於近日收到國家藥監局頒發的《醫療器械註冊證》。產品名稱:實時熒光定量PCR分析儀;註冊分類:III類;註冊證有效期:2023年3月15日至2028年3月13日;臨牀用途:該產品基於實時熒光PCR檢測原理,與配套的檢測試劑共同使用,在臨牀上用於對來源於人體樣本中的靶核酸(DNA/RNA)進行定性、定量檢測和熔解曲線檢測,包括病原體和人類基因項目。
該次獲得註冊證書的實時熒光定量PCR分析儀N904為公司分子平台新產品,該儀器能與公司熒光PCR試劑及校準品形成配套的分子檢測系統,進一步完善了公司的產品佈局。同時,公司的綜合競爭力與市場拓展能力也將得到提升,對公司未來的經營將產生積極影響。
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