Superoxide dismutase determination reagent kit (SOD substrate method) - NMPA Registration 京械注准20242400028
Access comprehensive regulatory information for Superoxide dismutase determination reagent kit (SOD substrate 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 京械注准20242400028 and owned by Beijing Enjihe Biological Engineering Co., Ltd.. The device was approved on January 16, 2024.
This page provides complete registration details including registrant information, province location (Beijing), 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 determination of the activity of superoxide dismutase in human serum or plasma.
用于体外定量测定人血清或血浆中的超氧化物歧化酶的活性。
The main components of reagent 1 are: Phosphate buffer 100mmol/L,pH6.8 The main components of reagent 2: Pyrogallol 1mmol/L The main components of the calibrator are: Phosphate buffer 50mmol/L,pH6.8 Superoxide dismutase 100.0~200.0U/mL Key components of the control: Phosphate buffer 50mmol/L,pH6.8 Superoxide dismutase Level 1: 70.0~150.0U/mL Level 2: 150.0~250.0U/mL Note: The calibrators and controls are batch-specific, and the specific concentrations are shown in the target value sheet.
试剂1主要组成成分: 磷酸盐缓冲液 100mmol/L,pH6.8 试剂2主要组成成分: 邻苯三酚 1mmol/L 校准品主要组成成分: 磷酸盐缓冲液 50mmol/L,pH6.8 超氧化物歧化酶 100.0~200.0U/mL 质控品主要组成成分: 磷酸盐缓冲液 50mmol/L,pH6.8 超氧化物歧化酶 水平1:70.0~150.0U/mL 水平2:150.0~250.0U/mL 注:校准品及质控品具有批特异性,具体浓度见靶值单。
2℃~8℃保存,
2℃~8℃保存,

