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α-L-Fucosidase Assay Kit (CNPF Substrate Method) - NMPA Registration 京械注准20242400072

Access comprehensive regulatory information for α-L-Fucosidase Assay Kit (CNPF 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20242400072 and owned by Beijing Baiao Taikang Biotechnology Co., Ltd.. The device was approved on February 07, 2024.

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20242400072
α-L-Fucosidase Assay Kit (CNPF Substrate Method)
α-L-岩藻糖苷酶测定试剂盒(CNPF底物法)
NMPA Registration Number: 京械注准20242400072
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Intended Use
English

The product is used for in vitro quantitative detection of alpha in human serum samples; -L-fucosidase activity.

中文

该产品用于体外定量检测人血清样本中alpha;-L-岩藻糖苷酶的活性。

Device Classification
Device Class
Class II
Model Specifications
试剂1:50mL; 6;试剂1:50mL; 5;试剂1:40mL; 4;试剂1:50mL; 3;试剂1:50mL; 2;试剂1:50mL; 1;试剂1:25mL; 1;试剂1:500mL; 1;试剂1:5000mL; 1.
试剂1:50mL;6;试剂1:50mL;5;试剂1:40mL;4;试剂1:50mL;3;试剂1:50mL;2;试剂1:50mL;1;试剂1:25mL;1;试剂1:500mL;1;试剂1:5000mL;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20242400072
Approval Date
February 07, 2024
Expiry Date
September 04, 2029
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、24号楼(科技创新功能区)
Structure and Composition
English

试剂1:Good#39; s缓冲液100mmol/L2-氯-4-硝基苯-alpha;-L-岩藻吡喃糖苷(CNPF)65mmol/L

中文

试剂1:Good#39;s缓冲液100mmol/L2-氯-4-硝基苯-alpha;-L-岩藻吡喃糖苷(CNPF)65mmol/L

Storage Conditions and Expiration
English

The product is stored at 2°C~8°C in the dark, and the expiration date is 18 months.

中文

该产品在2℃~8℃避光保存,有效期为18个月。

Additional Information
Remark
原注册证号:国械注准20153401100