Glycated hemoglobin calibration solution
- Device class
- Class II
- Model specifications
- 0.5mL/bottle× 2 bottles (lyophilized powder, 2 levels)0.5mL/瓶×2瓶（冻干粉，2个水平）
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20212401568
- Approval date
- November 17, 2021
- Expiry date
- November 16, 2026
- Name
- Jiangsu MDK BIOTECH Co., Ltd.江苏麦得科生物科技有限公司
- Province/Region
- Jiangsu江苏
- Address
- The third floor of the south building of Gaochuang Park, Shuyang County, Suqian City宿迁市沭阳县高创园南楼三层
- 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。
Access comprehensive regulatory information for Glycated hemoglobin calibration solution in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20212401568 and owned by Jiangsu MDK BIOTECH Co., Ltd.. The device was approved on November 17, 2021.
This page provides complete registration details including registrant information, province location (Jiangsu), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.