九強生物(300406.SZ):狼瘡抗凝物檢測試劑盒(凝固法)等7項產品取得醫療器械註冊證書
格隆匯1月14日丨九強生物(300406.SZ)公佈,2022年1月14日,公司收到北京市藥品監督管理局頒發的《醫療器械註冊證》,分別為:
1.狼瘡抗凝物檢測試劑盒(凝固法)。用於體外定性檢測人血漿中的狼瘡抗凝物。
2.凝血四項質控品。與北京美創新躍醫療器械有限公司生產的試劑盒配套使用,用於凝血酶原時間(PT)、活化部分凝血活酶時間(APTT)、凝血酶時間(TT)、纖維蛋白原(FIB)共四項的室內質量控制。
3.D-二聚體校準品。該產品與北京美創新躍醫療器械有限公司生產的D二聚體測定試劑盒配套使用,用於臨牀體外診斷中D-二聚體的校準。
4.D-二聚體質控品。該產品與北京美創新躍醫療器械有限公司生產的D二聚體測定試劑盒配套使用,用於臨牀體外診斷中D-二聚體的質量控制。
5.纖維蛋白原校準品。本產品與北京美創新躍醫療器械有限公司的纖維蛋白原測定試劑盒(凝固法)配套使用,用於纖維蛋白原檢測系統的校準。
6.纖維蛋白(原)降解產物(FDP)質控品。與北京美創新躍醫療器械有限公司生產的纖維蛋白(原)降解產物(FDP)(膠乳免疫比濁法)測定試劑盒配套使用,用於纖維蛋白(原)降解產物(FDP)項目的室內質量控制。
7.纖維蛋白(原)降解產物(FDP)校準品。與北京美創新躍醫療器械有限公司生產的纖維蛋白(原)降解產物(FDP)(膠乳免疫比濁法)測定試劑盒配套使用,用於纖維蛋白(原)降解產物(FDP)檢測系統的校準。
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