Acid phosphatase assay kit (α-naphthol phosphate method)
- 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 number
- 京械注准20242400733
- Approval date
- November 26, 2024
- Expiry date
- November 25, 2029
- 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 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
本产品用于体外定量测定人血清中酸性磷酸酶的含量.
本产品用于体外定量测定人血清中酸性磷酸酶的含量。
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.
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。
2°C~8°C storage, valid for 18 months.
2℃~8℃保存，有效期18个月。
- Remark
- 原注册证号：国械注准20153402294
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.