Thyroid-stimulating hormone assay kit (electrochemiluminescence) - NMPA Registration 浙械注准20242401791
Access comprehensive regulatory information for Thyroid-stimulating hormone assay kit (electrochemiluminescence) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 浙械注准20242401791 and owned by Ningbo Ruiyuan Biotechnology Co., Ltd.. The device was approved on September 19, 2024.
This page provides complete registration details including registrant information, province location (Zhejiang), 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.
This kit is used for the quantitative determination of the concentration of thyroid-stimulating hormone in human serum and plasma in vitro.
本试剂盒用于体外定量测定人血清和血浆中促甲状腺素的浓度。
Solid phase reagents, biotinylation reagents, ruthenium labeling reagents, calibrators (Cal1, Cal2), quality controls (L, H). (Please refer to the manual for details)
固相试剂、生物素化试剂、钌标记试剂、校准品（Cal1、Cal2）、质控品（L、H）。（具体内容详见说明书）
The reagent can be stored upright at 2~8°C and can be stable for 12 months. The calibrators and quality controls are stored at 2~8°C, and can be stable for 12 months when stored in the dark.
试剂在2～8℃避光条件下直立保存，可稳定12个月。校准品和质控品贮存于2～8℃，避光保存可稳定12个月。