Pure Global

Acid phosphatase assay kit (α-naphthol phosphate method) - NMPA Registration 京械注准20242400733

Access comprehensive regulatory information for Acid phosphatase assay kit (α-naphthol phosphate 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20242400733 and owned by Beijing Leadman Biochemistry Co., Ltd.. The device was approved on November 26, 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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
京械注准20242400733
Acid phosphatase assay kit (α-naphthol phosphate method)
酸性磷酸酶测定试剂盒(α-磷酸萘酚底物法)
NMPA Registration Number: 京械注准20242400733
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

本产品用于体外定量测定人血清中酸性磷酸酶的含量.

中文

本产品用于体外定量测定人血清中酸性磷酸酶的含量。

Device Classification
Device Class
Class II
Model Specifications
试剂1号:10;6mL、乙酸盐缓冲液:5mL;试剂1号:10;12mL、乙酸盐缓冲液:5mL;340测试/盒:[试剂1号:10;6mL、乙酸盐缓冲液:5mL].
试剂1号:10;6mL、乙酸盐缓冲液:5mL;试剂1号:10;12mL、乙酸盐缓冲液:5mL;340测试/盒:【试剂1号:10;6mL、乙酸盐缓冲液:5mL】。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400733
Approval Date
November 26, 2024
Expiry Date
November 25, 2029
Registrant
Name
Beijing Leadman Biochemistry Co., Ltd.
北京利德曼生化股份有限公司
Province/Region
Beijing
北京
Address
No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing
北京市北京经济技术开发区兴海路5号
Production Facility
Production Address
北京市北京经济技术开发区兴海路5号1幢2层、6层、B1层、2幢
Structure and Composition
English

试剂1号(干粉试剂溶解后的浓度):alpha;-磷酸萘胺:3mmol/L,柠檬酸钠:60mmol/L,PH=5.3;乙酸盐缓冲液:5M,PH=5.0.

中文

试剂1号(干粉试剂溶解后的浓度):alpha;-磷酸萘胺:3mmol/L,柠檬酸钠:60mmol/L,PH=5.3;乙酸盐缓冲液:5M,PH=5.0。

Storage Conditions and Expiration
English

2°C~8°C storage, valid for 18 months.

中文

2℃~8℃保存,有效期18个月。

Additional Information
Remark
原注册证号:国械注准20153402294