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科華生物(002022.SZ):全自動化學發光免疫分析儀獲醫療器械註冊證
格隆匯 04-20 16:19

格隆匯4月20日丨科華生物(002022.SZ)宣佈,近日,公司全資子公司上海科華實驗系統有限公司收到上海市藥品監督管理局頒發的一項《醫療器械註冊證》。

產品名稱:全自動化學發光免疫分析儀;適用範圍/預期用途:採用基於AMPPD和鹼性磷酸酶的間接化學發光法,與配套的檢測試劑共同使用,在臨牀上用於對來源於人體的血清、血漿樣本中的被分析物進行定性或定量檢測。

以上體外診斷儀器註冊證的取得,豐富了公司發光免疫產品線,將對公司業務發展具有正面影響,後續公司將積極推進“儀器+試劑”雙輪驅動的發展策略,做好新產品的上市推廣工作。

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