Renin detection kit (magnetic particle chemiluminescence) - NMPA Registration 湘械注准20232401017
Access comprehensive regulatory information for Renin detection kit (magnetic particle chemiluminescence) 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20232401017 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 renin in human plasma samples, and is mainly used for the auxiliary diagnosis of renal hypertension and endocrine hypertension in clinical practice.
用于体外定量检测人血浆样本中肾素（Renin）的浓度，临床上主要用于肾性高血压、内分泌型高血压的辅助诊断。
The product consists of R1, M, R2, calibrators, and quality controls. R1: buffer; M: 0.2 mg/mL magnetic particles conjugated to Renin antibody dissolved in buffer; R2: 0.5 μg/mL Renin antibody labeled with alkaline phosphatase in buffer; Calibration: Renin recombinant antigen dissolved in buffer, which should be lyophilized powder; Control: Renin 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Renin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Renin抗体溶于缓冲液中;校准品:Renin重组抗原溶于缓冲液中,应为冻干粉;质控品:Renin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。