β2-Microglobulin determination reagent kit (latex immunoturbidimetric method)
- Device class
- Class II
- Model specifications
- 试剂1(R1):20mL;2,试剂2(R2):10mL;1;试剂1(R1):40mL;1,试剂2(R2):10mL;1;试剂1(R1):41mL;1,试剂2(R2):13mL;1;试剂1(R1):44mL;2,试剂2(R2):12mL;2;试剂1(R1):74mL;2,试剂2(R2):20mL;2.试剂1（R1）：20mL;2，试剂2（R2）：10mL;1；试剂1（R1）：40mL;1，试剂2（R2）：10mL;1；试剂1（R1）：41mL;1，试剂2（R2）：13mL;1；试剂1（R1）：44mL;2，试剂2（R2）：12mL;2；试剂1（R1）：74mL;2，试剂2（R2）：20mL;2。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400771
- Approval date
- December 23, 2024
- Expiry date
- December 22, 2029
- Name
- Biosino BIO-TECHNOLOGY and Science INC.中生北控生物科技股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 27, Chaoqian Road, Science and Technology Park, Changping District, Beijing北京市昌平区科技园区超前路27号
- Production address
- 北京市昌平区科技园区超前路27号
用于体外定量测定人血清或尿液中beta;2-微球蛋白(beta;2-MG)的浓度.
用于体外定量测定人血清或尿液中beta;2-微球蛋白（beta;2-MG）的浓度。
1.试剂1(R1)三羟甲基氨基甲烷-盐酸(Tris-HCl)缓冲液(pH7.5)100mmol/L2.试剂2(R2)包被beta;2-微球蛋白(beta;2-MG)抗体的胶乳颗粒0.2w/v%
1.试剂1（R1）三羟甲基氨基甲烷-盐酸（Tris-HCl）缓冲液（pH7.5）100mmol/L2.试剂2（R2）包被beta;2-微球蛋白（beta;2-MG）抗体的胶乳颗粒0.2w/v%
2 °C ~ 8 °C stored in the dark, valid for 12 months.
2℃～8℃避光贮存，有效期12个月。
Access comprehensive regulatory information for β2-Microglobulin determination reagent kit (latex immunoturbidimetric 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20242400771 and owned by Biosino BIO-TECHNOLOGY and Science INC.. The device was approved on December 23, 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.