Total triiodothyronine quality control
- 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20242400389
- Approval date
- September 27, 2024
- Expiry date
- September 26, 2029
- Name
- Zybio Inc.中元汇吉生物技术股份有限公司
- Province/Region
- Chongqing重庆
- Address
- Floor 1-4, Building 30, No. 6 Taikang Road, Area C, Jianqiao Industrial Park, Dadukou District, Chongqing重庆市大渡口区建桥工业园C区太康路6号30栋第1-4层
- 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
This product is used in the total triiodothyronine detection kit (dry immunofluorescence method) produced by Zhongyuan Huiji Biotechnology Co., Ltd. for the quality control of the total triiodothyronine (TT3) detection system.
本产品配套中元汇吉生物技术股份有限公司生产的总三碘甲状腺原氨酸检测试剂盒（干式免疫荧光法）使用，用于总三碘甲状腺原氨酸（TT3）检测系统的质量控制。
This product is a lyophilized quality control containing different concentrations of T3 antigen (chemically synthesized) at levels 1:2.10-3.90 nmol/L, levels 2:4.20-7.80 nmol/L, buffer matrix is hormones-free bovine serum, and preservative is PC300.
本产品为冻干质控品，含有不同浓度的T3抗原（化学合成），水平1：2.10-3.90 nmol/L，水平2：4.20-7.80 nmol/L，缓冲基质为去激素牛血清，防腐剂为PC300。
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。
- Remark
- 首次注册。
Access comprehensive regulatory information for Total triiodothyronine quality control 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20242400389 and owned by Zybio Inc.. The device was approved on September 27, 2024.
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.