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China NMPA legacy archive 京械注准20242400771

β2-Microglobulin determination reagent kit (latex immunoturbidimetric method)

β2-微球蛋白测定试剂盒（胶乳免疫比浊法）
Biosino BIO-TECHNOLOGY and Science INC.Class IINMPAApproved December 23, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
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 information
Registration number
京械注准20242400771
Approval date
December 23, 2024
Expiry date
December 22, 2029
Registrant
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 facility
Production address
北京市昌平区科技园区超前路27号
Intended use
English

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.

中文

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。

Structure and composition
English

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%

中文

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%

Storage conditions and expiration
English

2 °C ~ 8 °C stored in the dark, valid for 12 months.

中文

2℃～8℃避光贮存，有效期12个月。

About this record

This static archive preserves historical registration fields and translations for β2-Microglobulin determination reagent kit (latex immunoturbidimetric method), registration 京械注准20242400771. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.