II型单纯疱疹病毒IgM抗体（HSV-II IgM）检测试剂盒（化学发光免疫分析法）
- Device class
- Class III
- Model specifications
- 100 servings/box100人份/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253400098
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
- Name
- Guangzhou Kangrun Biotechnology Co., Ltd.广州市康润生物科技有限公司
- Province/Region
- Guangdong广东
- Address
- No. 6 Nanjiang 2nd Road, Zhujiang Street, Nansha District, Guangzhou, 9 buildings (6# building) 13 floors广州市南沙区珠江街南江二路6号自编9栋（6#楼）13层
- Production address
- 广州市南沙区珠江街南江二路6 号自编7 栋（4#楼）1-3层、401、5-6 层
本试剂盒适用于体外定性检测人血清或血浆中的II型单纯疱疹病毒IgM抗体。
HSV-II磁珠包被物（R1）、抗人IgM抗体吖啶酯标记物（R2）、反应缓冲液（R3）、HSV-II IgM阴性对照、HSV-II IgM阳性对照、复溶液、阴阳性对照信息卡。（具体内容详见产品说明书）
Store at 2~8 °C in the dark, valid for 18 months.
2～8℃避光保存，有效期18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for II型单纯疱疹病毒IgM抗体（HSV-II IgM）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20253400098 and owned by Guangzhou Kangrun Biotechnology Co., Ltd.. The device was approved on January 10, 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.