Calcitonin detection kit (chemiluminescence method)
- Device class
- Class II
- Model specifications
- 1×50人份/盒、2×50人份/盒.1×50人份/盒、2×50人份/盒。
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20252400087
- Approval date
- January 15, 2025
- Expiry date
- January 14, 2030
- Name
- Shenzhen Yhlo Biotech Co., Ltd.深圳市亚辉龙生物科技股份有限公司
- Province/Region
- Guangdong广东
- Address
- Building 1, Yahuilong Biotechnology Factory, Baolong 2nd Road, Baolong Street, Longgang District, Shenzhen深圳市龙岗区宝龙街道宝龙二路亚辉龙生物科技厂区1栋
- 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。
- Appendix
- 产品技术要求、说明书
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.