Thyroid Stimulating Hormone 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20252400057
- 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促甲状腺激素检测试剂盒（干式免疫荧光法）使用，用于促甲状腺激素（TSH）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. This product is sealed and stored at 2°C~8°C, and the validity period is 6 months. 2. This product can be stored at 2°C~8°C for 8 hours after reconstitution; It can be stored at -25°C~-15°C for 30 days, and the number of repeated freeze-thaw is not more than 3 times.
1.本品2℃～8℃密封保存，有效期为6个月。2.本产品复溶后在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 Thyroid Stimulating Hormone 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20252400057 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.