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Glutathione reductase (GR) assay kit (glutathione substrate method) - NMPA Registration 京械注准20222400301

Access comprehensive regulatory information for Glutathione reductase (GR) 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 京械注准20222400301 and owned by Beijing Baiao Taikang Biotechnology Co., Ltd.. The device was approved on July 27, 2022.

This page provides complete registration details including registrant information, province location (Beijing), 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
京械注准20222400301
Glutathione reductase (GR) assay kit (glutathione substrate method)
谷胱甘肽还原酶（GR）测定试剂盒（谷胱甘肽底物法）
NMPA Registration Number: 京械注准20222400301
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Intended Use
English

For in vitro quantitative determination of glutathione reductase activity in human serum.

中文

用于体外定量测定人血清中谷胱甘肽还原酶的活性。

Device Classification
Device Class
Class II
Model Specifications
Reagent 1: 90mL times; 4, Reagent 2: 90mLtimes; 1;Reagent 1: 90mLtimes; 4, Reagent 2: 45mLtimes; 2; Reagent 1: 90mL times; 5, Reagent 2: 90mL times; 1;Reagent 1: 90mLtimes; 5, Reagent 2: 45mL times; 2; Reagent 1: 60mL times; 5, Reagent 2: 15mLtimes; 5; Reagent 1: 60mLtimes; 2, Reagent 2: 15mLtimes; 2; Reagent 1: 60mL times; 5, Reagent 2: 12mLtimes; 5; Reagent 1: 60mLtimes; 2, Reagent 2: 12mLtimes; 2; Reagent 1: 60mL times; 1, Reagent 2: 15mL times; 1; Reagent 1: 60mL times; 1, Reagent 2: 12mL times; 1; Reagent 1: 60mL times; 5, Reagent 2: 60mL times; 1; Reagent 1: 60mL times; 5, Reagent 2: 30mLtimes; 2; Reagent 1: 60mL times; 4, Reagent 2: 60mLtimes; 1; Reagent 1: 60mL times; 4, Reagent 2: 30mLtimes; 2; Reagent 1: 20mL times; 1, Reagent 2: 4mLtimes; 1;Reagent 1: 16mLtimes; 1, Reagent 2: 4mLtimes; 1; Reagent 1: 280mL times; 1, Reagent 2: 70mLtimes; 1; Reagent 1: 300mL times; 1, Reagent 2: 60mLtimes; 1; Reagent 1: 4000mL times; 1, Reagent 2: 1000mL times; 1; Reagent 1: 5000mL times; 1, Reagent 2: 1000mL times; 1; 400 servings (Reagent 1: 67mLtimes; 1, Reagent 2: 13mLtimes; 1); 400 servings (Reagent 1: 64mLtimes; 1, Reagent 2: 16mLtimes; 1); 1800 servings (Reagent 1: 288mLtimes; 1, Reagent 2: 72mLtimes; 1); 2000 servings (Reagent 1: 325mLtimes; 1, Reagent 2: 65mLtimes; 1); Calibrator (optional): 1mLtimes; 1; Control high value (optional): 1mLtimes; 1. Control low value (optional): 1mLtimes; 1.
试剂1:90mLtimes;4，试剂2:90mLtimes;1；试剂1:90mLtimes;4，试剂2:45mLtimes;2； 试剂1:90mLtimes;5，试剂2:90mLtimes;1；试剂1:90mLtimes;5，试剂2:45mLtimes;2； 试剂1:60mLtimes;5，试剂2:15mLtimes;5；试剂1:60mLtimes;2，试剂2:15mLtimes;2； 试剂1:60mLtimes;5，试剂2:12mLtimes;5；试剂1:60mLtimes;2，试剂2:12mLtimes;2； 试剂1:60mLtimes;1，试剂2:15mLtimes;1；试剂1:60mLtimes;1，试剂2:12mLtimes;1； 试剂1:60mLtimes;5，试剂2:60mLtimes;1；试剂1:60mLtimes;5，试剂2:30mLtimes;2； 试剂1:60mLtimes;4，试剂2:60mLtimes;1；试剂1:60mLtimes;4，试剂2:30mLtimes;2； 试剂1:20mLtimes;1，试剂2:4mLtimes;1；试剂1:16mLtimes;1，试剂2:4mLtimes;1； 试剂1:280mLtimes;1，试剂2:70mLtimes;1；试剂1:300mLtimes;1，试剂2:60mLtimes;1； 试剂1:4000mLtimes;1，试剂2:1000mLtimes;1； 试剂1:5000mLtimes;1，试剂2:1000mLtimes;1； 400人份(试剂1:67mLtimes;1，试剂2:13mLtimes;1)； 400人份(试剂1:64mLtimes;1，试剂2:16mLtimes;1)； 1800人份(试剂1:288mLtimes;1，试剂2:72mLtimes;1)； 2000人份(试剂1:325mLtimes;1，试剂2:65mLtimes;1)； 校准品(选配): 1mLtimes;1； 质控品高值(选配):1mLtimes;1；质控品低值(选配):1mLtimes;1。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20222400301
Approval Date
July 27, 2022
Expiry Date
July 26, 2027
Registrant
Name
Beijing Baiao Taikang Biotechnology Co., Ltd.
北京安图生物工程有限公司
Province/Region
Beijing
北京
Address
Building 17 and Building 18, No. 13 Mintai Road, Beiwu Town, Shunyi District, Beijing (Science and Technology Innovation Functional Area)
北京市顺义区北务镇民泰路13号院17号楼、18号楼(科技创新功能区)
Production Facility
Production Address
北京市顺义区北务镇民泰路13号院17号楼、18号楼（科技创新功能区）
Structure and Composition
English

ingredients concentration Reagent 1 R1 Phosphate buffer glutathione Stabilizer ge; 10mmol/L ge;0.01g/L ge;0.1% Reagent 2 R2 Good#39; S buffer Reduced Coenzyme II ge; 20mmol/L ge;0.01g/L Calibrator (Optional) Lyophilized Good#39; S buffer (GE; 20mmol/L) glutathione reductase Target concentration: 65U/L Controls Low value (Optional) Lyophilized Good#39; S buffer (GE; 20mmol/L) glutathione reductase Target concentration range: (35-65) U/L Controls High value (Optional) Lyophilized Good#39; S buffer (GE; 20mmol/L) glutathione reductase Target concentration range: (70-130) U/L The target value of the calibrator and the quality control range of the quality control are batch specific, see the bottle label for details.

中文

成分 浓度 试剂1 R1 磷酸盐缓冲液 谷胱甘肽 稳定剂 ge;10mmol/L ge;0.01g/L ge;0.1% 试剂2 R2 Good#39;s缓冲液 还原型辅酶Ⅱ ge;20mmol/L ge;0.01g/L 校准品 (选配) 冻干 Good#39;s缓冲液(ge;20mmol/L) 谷胱甘肽还原酶 目标浓度:65U/L 质控品 低值 (选配) 冻干 Good#39;s缓冲液(ge;20mmol/L) 谷胱甘肽还原酶 目标浓度范围:(35-65)U/L 质控品 高值 (选配) 冻干 Good#39;s缓冲液(ge;20mmol/L) 谷胱甘肽还原酶 目标浓度范围:(70-130)U/L 校准品靶值、质控品质控范围具有批特异性，详见瓶签。

Storage Conditions and Expiration
English

2 °C ~ 8 °C sealed and protected storage, the validity period is 12 months

中文

2℃～8℃密封避光贮存，有效期为12个月

Additional Information
Appendix
产品技术要求、说明书