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）
- Device class
- Class III
- Model specifications
- 2×50 servings/box (including calibrator), 2×100 servings/box (including calibrator)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 number
- 国械注准20253400187
- Approval date
- January 20, 2025
- Expiry date
- January 19, 2030
- Name
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.深圳迈瑞生物医疗电子股份有限公司
- Province/Region
- Guangdong广东
- Address
- Floor 1-4, Mindray Building, Keji South 12th Road, High-tech Industrial Park, Nanshan District, Shenzhen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 address
- 深圳市光明新区南环大道1203号
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。
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）
Store at 2~8°C, valid for 18 months.
2~8℃保存，有效期18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information 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） in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253400187 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was approved on January 20, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.