Thrombomodulin Assay Kit (Chemiluminescence) - NMPA Registration 粤械注准20252400133
Access comprehensive regulatory information for Thrombomodulin Assay Kit (Chemiluminescence) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20252400133 and owned by Shenzhen Yhlo Biotech Co., Ltd.. The device was approved on January 22, 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.
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。