China NMPA legacy archive 国械注准20253400104单纯疱疹病毒1+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 10, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- 2×50 人份/盒（含校准品）、2×100 人份/盒（含校准品）。
- Approval department
- State Drug Administration
国家药品监督管理局
Registration information
- Registration number
- 国械注准20253400104
- Approval date
- January 10, 2025
- Expiry date
- January 09, 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
产品用于体外定性检测人血清或血浆中的单纯疱疹病毒 1 型和 2 型特异性 IgG 抗体。
Structure and composition
English
试剂盒由磁珠包被物（Ra）、酶标记物（Rb）、样本处理液（Rc）、测试稀释液（Rd）、校准品组成，还包含条码。（具体内容详见产品说明书）
Storage conditions and expiration
English
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1+2型IgG抗体检测试剂盒（化学发光免疫分析法）, registration 国械注准20253400104. 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.