China NMPA legacy archive 粤械注准20252400087Calcitonin detection kit (chemiluminescence method)
降钙素测定试剂盒（化学发光法）
Shenzhen Yhlo Biotech Co., Ltd.Class IINMPAApproved January 15, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- 1×50人份/盒、2×50人份/盒.
- Approval department
- Guangdong Provincial Drug Administration
1×50人份/盒、2×50人份/盒。
广东省药品监督管理局
Registration information
- Registration number
- 粤械注准20252400087
- Approval date
- January 15, 2025
- Expiry date
- January 14, 2030
Registrant
- Province/Region
- Guangdong
- Address
- Building 1, Yahuilong Biotechnology Factory, Baolong 2nd Road, Baolong Street, Longgang District, Shenzhen
广东
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 facility
- 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
Intended use
English
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。
Structure and composition
English
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
Storage conditions and expiration
English
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。
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 Calcitonin detection kit (chemiluminescence method), registration 粤械注准20252400087. 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.