Free Testosterone (FT) Assay Kit (Magnetic Particle Chemiluminescence Method) - NMPA Registration 湘械注准20232401249
Access comprehensive regulatory information for Free Testosterone (FT) 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20232401249 and owned by Hunan XieGuang Biotechnology Co., Ltd.. The device was approved on December 20, 2023.
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.
It is used for in vitro quantitative detection of the concentration of free testosterone (FT) in human serum and plasma samples.
用于体外定量检测人血清、血浆样本中游离睾酮（FT）的浓度。
The product consists of R1, M, R2, calibrators, and quality controls. R1: buffer; M: 0.2 mg/mL magnetic particles conjugated to FT antibody dissolved in buffer; R2: 0.5 μg/mL F of labeled alkaline phosphatase dissolved in buffer; Calibrated Material: Chemically synthesized FT dissolved in buffer; Control: Chemically synthesized FT is dissolved in buffer.
产品由R1、M、R2、校准品、质控品组成。R1:缓冲液;M:0.2mg/mL已偶联FT抗体的磁微粒溶于缓冲液中;R2:0.5µg/mL已标记碱性磷酸酶的F溶于缓冲液中;校准品:化学合成的FT溶于缓冲液中;质控品:化学合成的FT溶于缓冲液中。
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。