China NMPA legacy archive 京械注准20252400506Direct bilirubin assay kit (vanadate oxidation)
直接胆红素测定试剂盒（钒酸盐氧化法）
Beijing Strong Biotechnologies,Inc.Class IINMPAApproved January 16, 2025
Static archiveNMPA · legacy registration snapshot
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20252400506
- Approval date
- January 16, 2025
- Expiry date
- January 15, 2030
Registrant
- Province/Region
- Beijing
- Address
- 5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing
北京
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;
Intended use
English
本试剂盒用于体外定量测定人血清中直接胆红素（D-BiL)的含量。
Structure and composition
English
试剂1：酒石酸缓冲液（pH 2.90）0.1mol/L；试剂 2：磷酸盐缓冲液（pH 7.00）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
- Appendix
- 产品技术要求、说明书
About this record
This static archive preserves historical registration fields and translations for Direct bilirubin assay kit (vanadate oxidation), registration 京械注准20252400506. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.