17α-Hydroxyprogesterone (17α-OHP) Assay Kit (Magnetic Particle Chemiluminescence Method) - NMPA Registration 湘械注准20232401018
Access comprehensive regulatory information for 17α-Hydroxyprogesterone (17α-OHP) 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20232401018 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 17α-hydroxyprogesterone (17α-OHP) in human serum and plasma samples, and is mainly used for the auxiliary diagnosis of adrenal cortex diseases in clinical practice.
用于体外定量检测人血清、血浆样本中17α-羟孕酮(17α-OHP)的浓度，临床上主要用于肾上腺皮质疾病的辅助诊断。
The product consists of R1, M, R2, calibrators, and quality controls. R1: buffer; M: 0.2 mg/mL magnetic particles conjugated to 17α-OHP antibody dissolved in buffer; R2: 0.5 μg/mL 17α-OHP labeled with alkaline phosphatase dissolved in buffer; Calibrator: 17α-OHP in buffer; Control: 17α-OHP 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17α-OHP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17α-OHP溶于缓冲液中;校准品:17α-OHP溶于缓冲液中;质控品:17α-OHP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。