Trans-triiodothyronine (rT3) Assay Kit (Magnetic Particle Chemiluminescence Method)
- Device class
- Class II
- Model specifications
- 25 tests/box, 50 tests/box, 100 tests/box, 150 tests/box, 200 tests/box, 500 tests/box25测试/盒、50测试/盒、100测试/盒、150测试/盒、200测试/盒、500测试/盒
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20242400267
- Approval date
- April 02, 2024
- Expiry date
- April 01, 2029
- Name
- Hunan XieGuang Biotechnology Co., Ltd.湖南携光生物技术有限公司
- Province/Region
- Hunan湖南
- Address
- The 2nd floor of the 2nd building of the medical device industrial park of the high-tech industrial development zone of Jinshi City, Hunan Province湖南省津市市高新技术产业开发区医疗器械产业园第2栋第2层
- Production address
- 湖南省津市市高新技术产业开发区医疗器械产业园第2栋第1层，第2层
It is used for in vitro quantitative detection of the concentration of transtriiodothyronine (rT3) in human serum samples.
用于体外定量检测人血清样本中反三碘甲状腺原氨酸（rT3）的浓度。
The unopened kit is stored in a closed and dark manner at 2 °C ~ 8 °C for 15 months, and it can be stable for 56 days after opening the bottle at 2 °C ~ 8 °C in the dark. Transportation and storage should be carried out under low temperature conditions of 2 °C ~ 8 °C.
未开瓶试剂盒于2℃～8℃密闭避光保存有效期为15个月，开瓶后2℃～8℃避光保存可稳定56天。运输和保存均应在2℃～8℃低温条件下进行。
Access comprehensive regulatory information for Trans-triiodothyronine (rT3) Assay Kit (Magnetic Particle Chemiluminescence Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20242400267 and owned by Hunan XieGuang Biotechnology Co., Ltd.. The device was approved on April 02, 2024.
This page provides complete registration details including registrant information, province location (Hunan), 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.