β2-Microglobulin determination reagent kit (latex immunoturbidimetric method) - NMPA Registration 京械注准20242400771

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.

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NMPA Official Data

Class II

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）

NMPA Registration Number: 京械注准20242400771

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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。

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

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。