China NMPA legacy archive 国械注准20253400187单纯疱疹病毒2型IgG抗体检测试剂盒（化学发光免疫分析法）
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
- 2×50 servings/box (including calibrator), 2×100 servings/box (including calibrator)
- Approval department
- State Drug Administration
2×50人份/盒（含校准品）、2×100人份/盒（含校准品）
国家药品监督管理局
Registration information
- Registration number
- 国械注准20253400187
- 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
本产品用于体外定性检测人血清或血浆中的单纯疱疹病毒2型特异性IgG抗体。
Structure and composition
English
磁珠包被物（Ra）、酶标记物（Rb）、样本处理液（Rc）、测试稀释液（Rd）、校准品。（具体详见说明书）
Storage conditions and expiration
English
Store at 2~8°C, valid for 18 months.
中文
2~8℃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 单纯疱疹病毒2型IgG抗体检测试剂盒（化学发光免疫分析法）, registration 国械注准20253400187. 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.