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α1-microglobulin calibration solution - NMPA Registration 渝械注准20242400510

Access comprehensive regulatory information for α1-microglobulin calibration solution in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 渝械注准20242400510 and owned by Chongqing Biostec Biological Technology Co., Ltd.. The device was approved on December 19, 2024.

This page provides complete registration details including registrant information, province location (Chongqing), 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
渝械注准20242400510
α1-microglobulin calibration solution
α1-微球蛋白校准品
NMPA Registration Number: 渝械注准20242400510
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Pricing
Intended Use
English

与本公司生产的α1-微球蛋白检测试剂盒(乳胶比浊法)配套使用,用于定量检测人体样本(血清或尿液)中α1-微球蛋白项目的系统校准.

中文

与本公司生产的α1-微球蛋白检测试剂盒(乳胶比浊法)配套使用,用于定量检测人体样本(血清或尿液)中α1-微球蛋白项目的系统校准。

Device Classification
Device Class
Class II
Model Specifications
5水平×1×0.5mL;5水平×1×1mL; 5水平×1×5mL;5水平×1×10mL.
5水平×1×0.5mL;5水平×1×1mL; 5水平×1×5mL;5水平×1×10mL。
Approval Department
Chongqing Municipal Drug Administration
重庆市药品监督管理局
Registration Information
Registration Number
渝械注准20242400510
Approval Date
December 19, 2024
Expiry Date
December 18, 2029
Registrant
Name
Chongqing Biostec Biological Technology Co., Ltd.
重庆博士泰生物技术有限公司
Province/Region
Chongqing
重庆
Address
1st and 2nd floor, Building 2, No. 17, Camellia Road, Changshengqiao Town, Nan'an District, Chongqing
重庆市南岸区长生桥镇茶花路17号2幢1、2楼
Production Facility
Production Address
重庆市南岸区茶花路17号2幢1楼、2楼、3楼2-1、2-2
Structure and Composition
English

由人源α1-微球蛋白抗原、牛血清白蛋白、蔗糖、氯化钠组成.(具体内容详见产品说明书)

中文

由人源α1-微球蛋白抗原、牛血清白蛋白、蔗糖、氯化钠组成。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

Unopened: 2~8°C storage, valid for 12 months. After the first opening: sealed at 2~8 °C, stable for 7 days. This product shall not freeze or thaw.

中文

未开封:2~8℃保存,有效期为12个月。首次开封后:2~8℃密封保存,可稳定7天。本品不得冻融。

Additional Information
Remark
首次注册。