China NMPA legacy archive 国械注准20253400198弓形虫IgM抗体（Toxo 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20253400198
- 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
本试剂盒适用于体外定性检测人血清或血浆中的弓形虫 IgM抗体。
Structure and composition
English
试剂盒由Toxo磁珠包被物（R1）、抗人IgM抗体吖啶酯标记物（R2）、反应缓冲液（R3）、Toxo IgM阴性对照、Toxo IgM阳性对照、复溶液和阴阳性对照信息卡组成。（具体信息详见产品说明书）
Storage conditions and expiration
English
未开封试剂，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 弓形虫IgM抗体（Toxo IgM）检测试剂盒（化学发光免疫分析法）, registration 国械注准20253400198. 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.