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Glutathione Reductase Assay Kit (Glutathione Substrate Method) - NMPA Registration 冀械注准20242400333

Access comprehensive regulatory information for Glutathione Reductase Assay Kit (Glutathione Substrate 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 冀械注准20242400333 and owned by Hebei Archi Biological Technology Co., Ltd.. The device was approved on August 20, 2024.

This page provides complete registration details including registrant information, province location (Hebei), 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
冀械注准20242400333
Glutathione Reductase Assay Kit (Glutathione Substrate Method)
谷胱甘肽还原酶测定试剂盒(谷胱甘肽底物法)
NMPA Registration Number: 冀械注准20242400333
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Intended Use
English

It is used for in vitro quantitative detection of glutathione reductase (GR) content in human serum.

中文

用于体外定量检测人体血清中谷胱甘肽还原酶(GR)的含量。

Device Classification
Device Class
Class II
Model Specifications
试剂1:25mL×1 试剂2:5mL×1; 试剂1:50mL×1 试剂2:10mL×1; 试剂1:50mL×2 试剂2:10mL×2; 试剂1:65mL×1 试剂2:13mL×1; 试剂1:65mL×2 试剂2:13mL×2; 试剂1:50mL×5 试剂2:50mL×1; 校准品:1mL×1(选购); 质控品:1mL×1(选购).
试剂1:25mL×1 试剂2:5mL×1; 试剂1:50mL×1 试剂2:10mL×1; 试剂1:50mL×2 试剂2:10mL×2; 试剂1:65mL×1 试剂2:13mL×1; 试剂1:65mL×2 试剂2:13mL×2; 试剂1:50mL×5 试剂2:50mL×1; 校准品:1mL×1(选购); 质控品:1mL×1(选购)。
Approval Department
Hebei Provincial Drug Administration
河北省药品监督管理局
Registration Information
Registration Number
冀械注准20242400333
Approval Date
August 20, 2024
Expiry Date
August 19, 2029
Registrant
Name
Hebei Archi Biological Technology Co., Ltd.
河北艾驰生物科技有限公司
Province/Region
Hebei
河北
Address
No. 789, Juxin Street, Qian'an High-tech Industrial Development Zone
迁安高新技术产业开发区聚鑫街789号
Production Facility
Production Address
迁安高新技术产业开发区聚鑫街789号
Structure and Composition
English

试剂1 三羟甲基氨基甲烷 20mmoL/L、氧化型谷胱甘肽 4mmoL/L 试剂2 三羟甲基氨基甲烷 20mmoL/L、NADPH 1.3mmoL/L 校准品 谷胱甘肽还原酶 定值浓度见瓶贴标示 质控品 谷胱甘肽还原酶 浓度范围见瓶贴标示

Storage Conditions and Expiration
English

The reagent is stable for 18 months when stored in a closed space at 2-8°C.

中文

试剂2-8℃密闭储存可稳定18个月。

Additional Information
Appendix
产品技术要求、说明书