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Total bilirubin determination reagent kit (vanadate oxidation method) - NMPA Registration 京械注准20252400505

Access comprehensive regulatory information for Total bilirubin determination reagent kit (vanadate oxidation 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20252400505 and owned by Beijing Strong Biotechnologies,Inc.. The device was approved on January 16, 2025.

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20252400505
Total bilirubin determination reagent kit (vanadate oxidation method)
总胆红素测定试剂盒(钒酸盐氧化法)
NMPA Registration Number: 京械注准20252400505
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Pricing
Intended Use
English

本试剂盒用于体外定量测定人血清中总胆红素(T-BiL)的含量。

Device Classification
Device Class
Class II
Model Specifications
试剂1:2×55 mL、试剂2:2×18 mL; 试剂1:2×51 mL、试剂2:2×17 mL; 892测试/盒; 830测试/盒。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20252400505
Approval Date
January 16, 2025
Expiry Date
January 15, 2030
Registrant
Name
Beijing Strong Biotechnologies,Inc.
北京九强生物技术股份有限公司
Province/Region
Beijing
北京
Address
5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing
北京市海淀区花园东路15号旷怡大厦5层
Production Facility
Production Address
北京市怀柔区雁栖经济开发区雁栖北二街15号
Structure and Composition
English

试剂 1:柠檬酸缓冲液 0.15mol/L;试剂 2:磷酸盐缓冲液 10mmol/L, 偏钒酸钠 4mmol/L。

Storage Conditions and Expiration
English

2℃~ 8℃密封避光保存,有效期 18 个月。

Additional Information
Changes
生产地址变更为:北京市怀柔区雁栖经济开发区雁栖北二街15号。
Appendix
产品技术要求、说明书