九強生物(300406.SZ)：13項產品取得醫療器械註冊證書
格隆匯12月9日丨九強生物(300406.SZ)公佈，2021年12月9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.丙酮酸測定試劑盒(乳酸脱氫酶法)，本試劑盒用於體外定量測定人血清中丙酮酸的含量。
2.β-羥丁酸測定試劑盒(β-羥丁酸脱氫酶法)，本試劑盒用於體外定量測定人血清或血漿中 β-羥丁酸(β-Hb)的含量。
3.糖化白蛋白測定試劑盒(過氧化物酶法)，本試劑盒用於體外定量測定人血清或血漿中糖化白蛋白(GA)和白蛋白(ALB)測量濃度的比值(%)。
4.銅測定試劑盒(PAESA顯色劑法)，本試劑盒用於體外定量測定人血清中銅(Cu)的含量。
5.1,5-脱水-D-山梨醇測定試劑盒(吡喃糖氧化酶法)，本試劑盒用於體外定量測定人血清或血漿中的1,5-脱水山梨醇(1,5-AG)含量。
6.載脂蛋白C3測定試劑盒(免疫比濁法)，本試劑盒用於體外定量測定人血清或血漿中載脂蛋白C3的含量。
7.乳酸脱氫酶同工酶1測定試劑盒(乳酸底物法)，本試劑盒用於體外定量測定人血清中乳酸脱氫酶同工酶1的含量。
8.唾液酸測定試劑盒(乳酸脱氫酶法)，本試劑盒用於體外定量測定人血清中的唾液酸的含量。
9.載脂蛋白CⅡ測定試劑盒(免疫比濁法)，本試劑盒用於體外定量測定人血清或血漿中載脂蛋白CⅡ的含量。
10.載脂蛋白A2測定試劑盒(免疫比濁法)，本試劑盒用於體外定量測定人血清或血漿中載脂蛋白 A2的含量。
11.血清澱粉樣蛋白A測定試劑盒(膠乳免疫比濁法)，本試劑盒用於體外定量測定人血清或血漿中的血清澱粉樣蛋白A的含量。
12.乙醇測定試劑盒(乙醇脱氫酶法)，本試劑盒用於體外定量測定人血清或血漿中的乙醇含量。
13.肌酸激酶同工酶測定試劑盒(膠乳免疫比濁法)，本試劑盒用於體外定量測定人血清或血漿中肌酸激酶同工酶(CKMB)的含量。
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