Calcitonin detection kit (chemiluminescence method) - NMPA Registration 粤械注准20252400087
Access comprehensive regulatory information for Calcitonin detection kit (chemiluminescence method) 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20252400087 and owned by Shenzhen Yhlo Biotech Co., Ltd.. The device was approved on January 15, 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清和（或）血浆中降钙素（CT）的含量，临床上主要用于甲状旁腺功能的辅助诊断。
主要由试剂1（R1）、试剂2（R2）、试剂3（R3）、校准品1（CAL1）、校准品2（CAL2）、校准品3（CAL3）组成。具体内容详见产品说明书
试剂及校准品未开封竖直存放于2～8℃：可稳定18个月。 试剂首次使用后存放于2～8℃：可稳定28天。 试剂2～8℃在机存放：可稳定28天。 校准品复溶后，在2～8℃冷藏下，可稳定3天；在室温（20～25℃）下，可稳定8小时；在-20～-25℃保存可稳定56天；冻融次数不得超过2次。