Glycated hemoglobin calibration solution
- Device class
- Class II
- Model specifications
- 0.5mL/bottle× 2 bottles (lyophilized powder, 2 levels)
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20212401568
- Approval date
- November 17, 2021
- Expiry date
- November 16, 2026
- Province/Region
- Jiangsu
- Address
- The third floor of the south building of Gaochuang Park, Shuyang County, Suqian City
- Production address
- 宿迁市沭阳县高创园南楼三层
It is used in conjunction with the glycated hemoglobin detection kit (enzymatic method) produced by Jiangsu Medeco Biotechnology Co., Ltd. for the calibration of clinical laboratory testing systems.
与江苏麦得科生物科技有限公司生产的糖化血红蛋白检测试剂盒(酶法)配套使用,用于临床实验室检测系统的校准。
fetal bovine serum, ≥ 90%; Glycated hemoglobin (recombinant protein, source: E. coli), level 1: 4.5~7.5%, level 2: 8~14%; ProClin-300,0.03%.
胎牛血清,≥90%;糖化血红蛋白(重组蛋白,来源:大肠杆菌),水平1:4.5~7.5%,水平2:8~14%;ProClin-300,0.03%。
1.2 °C ~ 8 °C sealed storage, valid for 12 months. 2. After reconstitution, it is stored at 2~8 °C in the dark, which can be stable for 7 days.
1.2℃~8℃密封储存,有效期12个月。2.复溶后置于2~8℃避光储存,可稳定7天。
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