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Glutathione Reductase Detection Kit (Rate Method) - NMPA Registration 苏械注准20212401388

Access comprehensive regulatory information for Glutathione Reductase Detection Kit (Rate Method) 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20212401388 and owned by Jiangsu MDK BIOTECH Co., Ltd.. The device was approved on September 29, 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.

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Class II
苏械注准20212401388
Glutathione Reductase Detection Kit (Rate Method)
谷胱甘肽还原酶检测试剂盒(速率法)
NMPA Registration Number: 苏械注准20212401388
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Intended Use
English

For in vitro quantitative detection of glutathione reductase (GR) activity in human serum samples.

中文

用于体外定量检测人体血清样本中谷胱甘肽还原酶(GR)的活性。

Device Classification
Device Class
Class II
Model Specifications
See Specifications/Model Accessories
见规格/型号附件
Approval Department
Jiangsu Provincial Drug Administration
江苏省药品监督管理局
Registration Information
Registration Number
苏械注准20212401388
Approval Date
September 29, 2021
Expiry Date
September 28, 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
Structure and Composition
English

Reagent 1: Phosphate buffer pH=7.3 250mmol/L reduced nicotinamide adenine dinucleotide phosphate (NADPH) 0.17mmol/Lproclin-300 0.03% Reagent 2: Glutathione (GSSG) 2.2mmol/L disodium edta-2Na 0.5mmol/Lproclin-300 0.03%

中文

试剂1:磷酸盐缓冲液 pH=7.3 250mmol/L还原型烟酰胺腺嘌呤二核苷酸磷酸(NADPH) 0.17mmol/Lproclin-300 0.03%试剂2:谷胱甘肽(GSSG) 2.2mmol/L乙二胺四乙酸二钠(EDTA-2Na) 0.5mmol/Lproclin-300 0.03%

Storage Conditions and Expiration
English

1.2 °C ~ 8 °C sealed storage, valid for 12 months. 2.2 °C ~ 8 °C open and stable for 28 days.

中文

1.2℃~8℃密封储存,有效期12个月。2.2℃~8℃开瓶稳定28天。