α-L-Fucosidase Control
- Device class
- Class II
- Model specifications
- 低值:1; 1mL;2; 1mL;高值:1; 1mL;2; 1mL.低值：1;1mL；2;1mL；高值：1;1mL；2;1mL。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400070
- Approval date
- February 07, 2024
- Expiry date
- July 25, 2029
- 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 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）
Alpha produced with the company; -L-fucosidase assay kit (CNPF substrate method) is used for alpha; Quality control of L-fucosidase project.
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-岩藻糖苷酶项目的质量控制。
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)低值:(20-50]U/L高值:(50-100)U/L注:质控品具有批特异性,具体定值详见瓶签.
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）低值：(20-50]U/L高值：(50-100)U/L注：质控品具有批特异性，具体定值详见瓶签。
The product is stored at 2°C~8°C in the dark, and the expiration date is 18 months.
该产品在2℃～8℃避光保存，有效期为18个月。
- Remark
- 原注册证号：国械注准20193400534
Access comprehensive regulatory information for α-L-Fucosidase Control 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20242400070 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.