Sex Hormone Binding Globulin (SHBG) Assay Kit (Magnetic Particle Chemiluminescence Method) - NMPA Registration 湘械注准20232401015
Access comprehensive regulatory information for Sex Hormone Binding Globulin (SHBG) 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20232401015 and owned by Hunan XieGuang Biotechnology Co., Ltd.. The device was approved on October 24, 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 sex hormone-binding globulin (SHBG) in human serum and plasma samples, and is mainly used for the auxiliary diagnosis of a variety of androgen abnormalities in clinical practice.
用于体外定量检测人血清、血浆样本中性激素结合球蛋白(SHBG)的浓度,临床上主要用于多种雄激素异常疾病的辅助诊断。
The product consists of R1, M, R2, calibrators, and quality controls. R1: buffer; M: 0.2 mg/mL magnetic particles conjugated to SHBG antibody dissolved in buffer; R2: 0.5 μg/mL SHBG antibody labeled with alkaline phosphatase dissolved in buffer; Calibrator: SHBG recombinant antigen is dissolved in buffer and should be lyophilized powder; Control: SHBG recombinant antigen is dissolved in buffer and should be lyophilized powder.
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SHBG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SHBG抗体溶于缓冲液中;校准品:SHBG重组抗原溶于缓冲液中,应为冻干粉;质控品:SHBG重组抗原溶于缓冲液中,应为冻干粉。
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. After reconstitution of calibrators and quality control products, they can be stored for 7 days under the condition of 2 °C ~ 8 °C, and 56 days under the condition of -20 °C. 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。校准品、质控品复溶后在2℃～8℃条件下可保存7天，在-20℃条件下可保存56天。运输和保存均应在2℃～8℃低温条件下进行。