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α2-Globulin Determination Reagent Kit (Immune Turbidimetry) - NMPA Registration 冀械注准20242400418

Access comprehensive regulatory information for α2-Globulin Determination Reagent Kit (Immune Turbidimetry) 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20242400418 and owned by Hebei Archi Biological Technology Co., Ltd.. The device was approved on November 07, 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20242400418
α2-Globulin Determination Reagent Kit (Immune Turbidimetry)
α2-巨球蛋白测定试剂盒(免疫比浊法)
NMPA Registration Number: 冀械注准20242400418
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Intended Use
English

It is used for the quantitative determination of α2-macroglobulin (α2-MG) in human serum in vitro.

中文

用于体外定量测定人血清中α2-巨球蛋白 (α2-MG)的含量。

Device Classification
Device Class
Class II
Model Specifications
试剂1:30mL×1 试剂2:10mL×1; 试剂1:40mL×3 试剂2:40mL×1; 试剂1:60mL×1 试剂2:20mL×1; 试剂1:60mL×2 试剂2:20mL×2; 试剂1:60mL×3 试剂2:60mL×1; 校准品:0.5mL×4(选购); 质控品:0.5mL×1(选购).
试剂1:30mL×1 试剂2:10mL×1; 试剂1:40mL×3 试剂2:40mL×1; 试剂1:60mL×1 试剂2:20mL×1; 试剂1:60mL×2 试剂2:20mL×2; 试剂1:60mL×3 试剂2:60mL×1; 校准品:0.5mL×4(选购); 质控品:0.5mL×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20242400418
Approval Date
November 07, 2024
Expiry Date
November 06, 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, Eastern Area, Qian'an Economic Development Zone, Hebei Province
河北迁安经济开发区东部片区聚鑫街789号
Production Facility
Production Address
河北迁安经济开发区东部片区聚鑫街789号
Structure and Composition
English

试剂1 三羟甲基氨基甲烷 20mmol/L、PEG6000 5% 试剂2 三羟甲基氨基甲烷 20mmol/L、羊抗人α2-巨球蛋白多克隆抗体 15.0% 校准品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白(BSA) 1%、重组α2-巨球蛋白 质控品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白(BSA) 1%、重组α2-巨球蛋白

中文

试剂1 三羟甲基氨基甲烷 20mmol/L、PEG6000 5% 试剂2 三羟甲基氨基甲烷 20mmol/L、羊抗人α2-巨球蛋白多克隆抗体 15.0% 校准品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白(BSA) 1%、重组α2-巨球蛋白 质控品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白(BSA) 1%、重组α2-巨球蛋白

Storage Conditions and Expiration
English

试剂、校准品和质控品2-8℃密闭储存可稳定18个月.

中文

试剂、校准品和质控品2-8℃密闭储存可稳定18个月。

Additional Information
Appendix
产品技术要求、说明书