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β2-microglobulin calibration material - NMPA Registration 京械注准20242400625

Access comprehensive regulatory information for β2-microglobulin calibration material 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20242400625 and owned by Biosino BIO-TECHNOLOGY and Science INC.. The device was approved on November 08, 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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Class II
京械注准20242400625
β2-microglobulin calibration material
β2-微球蛋白校准品
NMPA Registration Number: 京械注准20242400625
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Pricing
Intended Use
English

与本公司beta;2-微球蛋白测定试剂盒(胶乳免疫比浊法)配套使用,用于临床检验实验室测定尿液样本beta;2-微球蛋白项目定量检测的系统校准.

中文

与本公司beta;2-微球蛋白测定试剂盒(胶乳免疫比浊法)配套使用,用于临床检验实验室测定尿液样本beta;2-微球蛋白项目定量检测的系统校准。

Device Classification
Device Class
Class II
Model Specifications
1mL;4
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400625
Approval Date
November 08, 2024
Expiry Date
November 07, 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

磷酸盐缓冲液,10mmol/L;4个浓度,目标浓度分别为浓度2:0.25mg/L、浓度3:0.50mg/L、浓度4:1.50mg/L、浓度5:6.00mg/L.每批定值,值有批特异性,详见值单.

中文

磷酸盐缓冲液,10mmol/L;4个浓度,目标浓度分别为浓度2:0.25mg/L、浓度3:0.50mg/L、浓度4:1.50mg/L、浓度5:6.00mg/L。每批定值,值有批特异性,详见值单。

Storage Conditions and Expiration
English

2℃~8℃贮存,有效期18个月.

中文

2℃~8℃贮存,有效期18个月。

Additional Information
Changes
产品过期日期变更为:2℃~8℃贮存,有效期18个月。。
Appendix
产品技术要求、说明书