China NMPA legacy archive 渝械注准2025240005625-hydroxyvitamin D quality control material
25-羟基维生素D质控品
Zybio Inc.Class IINMPAApproved January 26, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- 2-level × 1 bottle × 0.5 mL, 2-level × 1 bottle × 1.0 mL
- Approval department
- Chongqing Municipal Drug Administration
2水平×1瓶×0.5mL、2水平×1瓶×1.0mL
重庆市药品监督管理局
Registration information
- Registration number
- 渝械注准20252400056
- Approval date
- January 26, 2025
- Expiry date
- January 25, 2030
Registrant
- Province/Region
- Chongqing
- Address
- 重庆市大渡口区跳磴镇石林大道45号
重庆
Production facility
- Production address
- 重庆市大渡口区建桥工业园C区太康路10号27-28栋第1-4层
Intended use
English
本产品配套中元汇吉生物技术股份有限公司生产的25-羟基维生素D检测试剂盒（干式免疫荧光法）使用，用于25-羟基维生素D（25-OH-VD）检测系统的质量控制。
Structure and composition
English
本产品为冻干质控品(具体内容详见产品说明书)。
Storage conditions and expiration
English
1.本品2℃～8℃密封保存，有效期为6个月。2.开盖复溶后在2℃～8℃可保存8小时；在-25℃～-15℃可保存30天，反复冻融次数不大于3次。
About this record
This static archive preserves historical registration fields and translations for 25-hydroxyvitamin D quality control material, registration 渝械注准20252400056. 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.