25-hydroxyvitamin D quality control material
- Device class
- Class II
- Model specifications
- 2-level × 1 bottle × 0.5 mL, 2-level × 1 bottle × 1.0 mL2水平×1瓶×0.5mL、2水平×1瓶×1.0mL
- Approval department
- Chongqing Municipal Drug Administration重庆市药品监督管理局
- Registration number
- 渝械注准20252400056
- Approval date
- January 26, 2025
- Expiry date
- January 25, 2030
- Name
- Zybio Inc.中元汇吉生物技术股份有限公司
- Province/Region
- Chongqing重庆
- Address
- 重庆市大渡口区跳磴镇石林大道45号
- 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
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。
本产品为冻干质控品(具体内容详见产品说明书)。
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。
Access comprehensive regulatory information for 25-hydroxyvitamin D quality control material in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 渝械注准20252400056 and owned by Zybio Inc.. The device was approved on January 26, 2025.
This page provides complete registration details including registrant information, province location (Chongqing), 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.