China NMPA legacy archive 国械注准20253400206风疹病毒IgM抗体（Rub IgM）检测试剂盒（化学发光免疫分析法）
Guangzhou Kangrun Biotechnology Co., Ltd.Class IIINMPAApproved January 20, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- 100 servings/box
- Approval department
- State Drug Administration
100人份/盒
国家药品监督管理局
Registration information
- Registration number
- 国械注准20253400206
- Approval date
- January 20, 2025
- Expiry date
- January 19, 2030
Registrant
- Province/Region
- Guangdong
- Address
- No. 6 Nanjiang 2nd Road, Zhujiang Street, Nansha District, Guangzhou, 9 buildings (6# building) 13 floors
广东
广州市南沙区珠江街南江二路6号自编9栋（6#楼）13层
Production facility
- 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
Intended use
English
适用于体外定性检测人血清或血浆中的风疹病毒IgM抗体。
Structure and composition
English
由Rub磁珠包被物（R1）、抗人IgM抗体吖啶酯标记物（R2）、反应缓冲液（R3）、Rub IgM阴性对照、Rub IgM阳性对照、复溶液和阴阳性对照信息卡组成。（具体详见说明书）
Storage conditions and expiration
English
Store at 2~8 °C in the dark, valid for 18 months.
中文
2～8℃避光保存，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 风疹病毒IgM抗体（Rub IgM）检测试剂盒（化学发光免疫分析法）, registration 国械注准20253400206. 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.