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China NMPA legacy archive 苏械注准20212401568

Glycated hemoglobin calibration solution

糖化血红蛋白校准品
Jiangsu MDK BIOTECH Co., Ltd.Class IINMPAApproved November 17, 2021
Static archiveNMPA · legacy registration snapshot
Device classification
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 information
Registration number
苏械注准20212401568
Approval date
November 17, 2021
Expiry date
November 16, 2026
Registrant
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 facility
Production address
宿迁市沭阳县高创园南楼三层
Intended use
English

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.

中文

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。

Structure and composition
English

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%.

中文

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%。

Storage conditions and expiration
English

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.

中文

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。

About this record

This static archive preserves historical registration fields and translations for Glycated hemoglobin calibration solution, registration 苏械注准20212401568. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.