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α-L-Fucosidase Calibration Solution - NMPA Registration 京械注准20242400071

Access comprehensive regulatory information for α-L-Fucosidase Calibration Solution 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20242400071 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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NMPA Official Data
Class II
京械注准20242400071
α-L-Fucosidase Calibration Solution
α-L-岩藻糖苷酶校准品
NMPA Registration Number: 京械注准20242400071
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Pricing
Intended Use
English

Alpha produced with the company; -L-fucosidase assay kit (CNPF substrate method) is used for alpha; -Calibration of the L-fucosidase kit detection system.

中文

与该公司生产的alpha;-L-岩藻糖苷酶测定试剂盒(CNPF底物法)配套使用,用于alpha;-L-岩藻糖苷酶试剂盒检测系统的校准。

Device Classification
Device Class
Class II
Model Specifications
1; 1mL
1;1mL
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400071
Approval Date
February 07, 2024
Expiry Date
July 25, 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

组分浓度磷酸盐缓冲液11.4mmol/L牛血清白蛋白lt; 5%alpha;-L-岩藻糖苷酶(基因重组)(30-80)U/L注:校准品具有批特异性,具体定值详见瓶签.

中文

组分浓度磷酸盐缓冲液11.4mmol/L牛血清白蛋白lt;5%alpha;-L-岩藻糖苷酶(基因重组)(30-80)U/L注:校准品具有批特异性,具体定值详见瓶签。

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20193400530