China NMPA legacy archive 粤械注准20252400133Thrombomodulin Assay Kit (Chemiluminescence)
- Device class
- Class II
- Model specifications
- 2×50 servings/box
- Approval department
- Guangdong Provincial Drug Administration
- Registration number
- 粤械注准20252400133
- Approval date
- January 22, 2025
- Expiry date
- January 21, 2030
- Province/Region
- Guangdong
- Address
- Building 1, Yahuilong Biotechnology Factory, Baolong 2nd Road, Baolong Street, Longgang District, Shenzhen
- Production address
- 深圳市龙岗区宝龙街道宝龙二路亚辉龙生物科技厂区2栋
用于体外定量测定人血浆中血栓调节蛋白 TM 的含量，主要用于血栓疾病的辅助诊断。
试剂1（R1）：血栓调节蛋白抗体（鼠源）包被的超顺磁性微粒，含防腐剂（ProClin 300）；试剂2（R2）：血栓调节蛋白抗体（鼠源）吖啶标记结合物，含防腐剂（ProClin 300）；校准品1（CAL1）：磷酸盐缓冲液，含蛋白稳定剂、防腐剂（ProClin 300）；校准品2（CAL2）：磷酸盐缓冲液，含血栓调节蛋白（HEK293细胞表达）、蛋白稳定剂、防腐剂（ProClin 300）；校准品3（CAL3）：磷酸盐缓冲液，含血栓调节蛋白（HEK293细胞表达）、蛋白稳定剂、防腐剂（ProClin 300）。
试剂及校准品未开封竖直存放于2～8℃：可稳定18个月。试剂及校准品首次使用后存放于2～8℃：可稳定56天。试剂2～8℃在机存放：可稳定56天。生产日期和失效日期见包装标签。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Thrombomodulin Assay Kit (Chemiluminescence), registration 粤械注准20252400133. It does not establish current authorization or complete current product details.
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