Glycated hemoglobin calibration solution - NMPA Registration 苏械注准20212401568
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.
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。