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Retinol binding protein calibration solution - NMPA Registration 渝械注准20252400001

Access comprehensive regulatory information for Retinol binding protein 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20252400001 and owned by Chongqing Biostec Biological Technology Co., Ltd.. The device was approved on January 02, 2025.

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20252400001
Retinol binding protein calibration solution
视黄醇结合蛋白校准品
NMPA Registration Number: 渝械注准20252400001
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Pricing
Intended Use
English

与本公司生产的视黄醇结合白蛋白检测试剂盒(胶乳增强免疫比浊法)、视黄醇结合蛋白检测试剂盒(散射比浊法)配套使用,用于视黄醇结合蛋白项目定量测定时的系统校准。

Device Classification
Device Class
Class II
Model Specifications
校准品(4水平):4水平×1×0.5mL;4水平×1×1mL; 4水平×1×5mL;4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20252400001
Approval Date
January 02, 2025
Expiry Date
January 01, 2030
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

视黄醇结合蛋白校准品的主要组成成分为重组视黄醇结合蛋白抗原、牛血清白蛋白、蔗糖、氯化钠。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

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。

Additional Information
Remark
首次注册。