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*ST科華(002022.SZ): 2項新產品取得藥品註冊證書、醫療器械註冊證
格隆匯 08-01 16:16

格隆匯8月1日丨*ST科華(002022.SZ)公佈,公司近日收到國家藥品監督管理局頒發的《藥品註冊證書》、上海市藥品監督管理局頒發的《醫療器械註冊證》(體外診斷試劑)。包括:

產品名稱:人類免疫缺陷病毒抗原抗體診斷試劑盒(酶聯免疫法);適用範圍/預期用途:用於體外定性檢測人血清或血漿樣本中的HIV-1型和HIV-2型抗體以及HIV-1P24抗原。

產品名稱:胃泌素17(G-17)測定試劑盒(化學發光法);適用範圍/預期用途:供醫療機構用於體外定量測定人血清樣本中胃泌素17(Gastrin-17,G-17)的濃度。

公司表示,以上新產品藥品註冊證書、醫療器械註冊證的取得,豐富了公司產品線,將對公司業務發展具有正面影響。

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