科華生物(002022.SZ):全自動PCR分析系統獲得醫療器械註冊證
格隆匯11月4日丨科華生物(002022.SZ)公佈,近日,公司控股子公司西安天隆科技有限公司收到國家藥品監督管理局頒發的一項《醫療器械註冊證》。
產品名稱為全自動PCR分析系統,註冊證有效期為2019年9月29日至2024年9月28日;適用範圍/預期用途:該產品基於熒光聚合酶鏈式反應(PCR)原理,與適配試劑配合使用,用於人體樣本中的靶核酸(DNA/RNA)的定性、定量及熔解度檢測,包括致病性病原體核酸和人類基因等檢測相關的項目。
以上新產品醫療器械註冊證的取得,豐富了公司產品線,將對公司發展具有正面影響。
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