Total bilirubin determination reagent kit (vanadate oxidation method)
- 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 number
- 京械注准20252400505
- Approval date
- January 16, 2025
- Expiry date
- January 15, 2030
- 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 address
- 北京市怀柔区雁栖经济开发区雁栖北二街15号
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。
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。
2℃~ 8℃密封避光保存，有效期 18 个月。
- 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
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.