China NMPA legacy archive 国械注准20253400188幽门螺杆菌IgG抗体质控品
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Class IIINMPAApproved January 20, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- 幽门螺杆菌IgG抗体质控品（阴性）：3×0.60 mL、6×0.60 mL、3×2.0 mL、6×2.0 mL；幽门螺杆菌IgG抗体质控品（阳性）：3×0.60 mL、6×0.60 mL、3×2.0 mL、6×2.0 mL。
- Approval department
- State Drug Administration
国家药品监督管理局
Registration information
- Registration number
- 国械注准20253400188
- Approval date
- January 20, 2025
- Expiry date
- January 19, 2030
Registrant
- Province/Region
- Guangdong
- Address
- Floor 1-4, Mindray Building, Keji South 12th Road, High-tech Industrial Park, Nanshan District, Shenzhen
广东
深圳市南山区高新技术产业园区科技南十二路迈瑞大厦1-4层
Production facility
- Production address
- 深圳市光明新区南环大道1203号
Intended use
English
与本公司生产的幽门螺杆菌IgG抗体检测试剂盒（化学发光免疫分析法）及幽门螺杆菌IgG抗体对照品配合使用，对检测项目幽门螺杆菌IgG抗体进行质量控制。
Structure and composition
English
幽门螺杆菌IgG抗体质控品（阴性）：约0.6COI，含幽门螺杆菌IgG抗体人血清、牛血清白蛋白的MES缓冲液，防腐剂（ProClin300，NaN3）。幽门螺杆菌IgG抗体质控品（阳性）：约3.0COI，含幽门螺杆菌IgG抗体人血清、牛血清白蛋白的MES缓冲液，防腐剂（ProClin300，NaN3）。
Storage conditions and expiration
English
Store at 2~8°C, valid for 18 months.
中文
2~8℃保存，有效期为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 幽门螺杆菌IgG抗体质控品, registration 国械注准20253400188. 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.