总三碘甲状腺原氨酸（TT3）测定试剂盒（电化学发光法）
- Device class
- Class II
- Model specifications
- 50 tests/box, 2×50 tests/box, 100 tests/box, 2×100 tests/box50测试/盒、2×50测试/盒、100测试/盒、2×100测试/盒
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20252400145
- Approval date
- January 23, 2025
- Expiry date
- January 22, 2030
- Name
- Shenzhen Lifotronic Technology Co., Ltd.深圳普门科技股份有限公司
- Province/Region
- Guangdong广东
- Address
- Pumen Science and Technology Headquarters Building, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua District, Shenzhen深圳市龙华区观湖街道观城社区求知东路8号普门科技总部大厦
- Production address
- 广东省东莞市松山湖园区彰化路2号1号厂房2-11楼（委托生产）
用于体外定量测定人血清或血浆样本中总三碘甲状腺原氨酸（TT3）的含量，临床上用于甲状腺疾病的辅助诊断。
本产品由磁珠溶液（MB）、生物素标记物（RB）、钌标记物（RA）、校准品、质控品（选配）组成。磁珠溶液：包被有链霉亲和素的磁性微粒，0.75mg/mL； ProClin300。生物素标记物（RB）：生物素标记的三碘甲状腺原氨酸（T3）兔单克隆抗体；磷酸盐（PBS）缓冲液；ProClin300。钌标记物（RA）：钌复合物标记的三碘甲状腺原氨酸（T3）兔单克隆抗体；磷酸盐（PBS）缓冲液；ProClin300；校准品：磷酸盐缓冲液、T3 抗原（化学合成）、ProClin300；质控品（选配）：磷酸盐缓冲液、T3 抗原（化学合成）、ProClin300。
未开封试剂及配套校准品和质控品2～8℃保存，有效期18 个月；开封试剂及配套校准品和质控品2～8℃可保存8 周；试剂在机（温度2～15℃）可保存8 周；
- Remark
- 受托生产企业：广东普门生物医疗科技有限公司；统一社会信用代码：91441900MA4UHLWH4C。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 总三碘甲状腺原氨酸（TT3）测定试剂盒（电化学发光法） in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20252400145 and owned by Shenzhen Lifotronic Technology Co., Ltd.. The device was approved on January 23, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.