Biochemical composite control level 1 - NMPA Registration 京械注准20232400670
Access comprehensive regulatory information for Biochemical composite control level 1 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20232400670 and owned by Beijing WantaiDerui Diagnostic Technology Co., Ltd.. The device was approved on October 19, 2023.
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.
This product is used in conjunction with the kits produced by the company for in-house quality control of clinical testing items. This product contains the following 7 items: Adenosine deaminase (ADA), beta;-hydroxybutyric acid (beta;-HBA), superoxide dismutase (SOD), total bile acids (TBA), carbon dioxide (CO2), lactic acid (LAC), free fatty acids (NEFA).
本产品与本公司生产的试剂盒配套使用，用于临床检测项目的室内质量控制。本产品具体包含以下7个项目： 腺苷脱氨酶（ADA)、beta;-羟丁酸(beta;-HBA)、超氧化物歧化酶(SOD)、总胆汁酸(TBA)、二氧化碳(CO2)、乳酸(LAC)、游离脂肪酸(NEFA)。
Lyophilized powder, in the serum matrix, add the substances in Table 1. Table 1 Composition and target ranges sequence number The name of the project (Abbreviation) detect method Biological origin Target range unit 1 Adenosine deaminase (ADA) Peroxidase method Recombinant expression 13.0-30.0 U/L 2 beta;-hydroxybutyrate (beta;-HBA) beta;-hydroxybutyrate dehydrogenase method chemosynthesis 125-200 mu; mol/L 3 Superoxide dismutase (SOD) Pyrogallol method extract 25.0-80.0 U/mL 4 Total bile acids (TBA) Enzymatic cycle method extract 4.00-19.00 mu; mol/L 5 Carbon dioxide (CO2) PEPC enzymatic method synthesis 10.0-20.0 mmol/L 6 Lactic acid (LAC) Lactate oxidase method synthesis 1.00-2.20 mmol/L 7 Free Fatty Acids (NEFA) ACS-ACOD method synthesis 0.200-0.500 mmol/L Batch-specific, see target value list for specific concentrations.
冻干粉，在血清基质中，添加表1中的物质。 表 1组成及靶值范围 序 号 项目名称 (缩写) 检测 方法 生物学来源 靶值范围 单位 1 腺苷脱氨酶（ADA) 过氧化物酶法 重组表达 13.0-30.0 U/L 2 beta;-羟丁酸(beta;-HBA) beta;-羟丁酸脱氢酶法 化学合成 125-200 mu;mol/L 3 超氧化物歧化酶(SOD) 邻苯三酚法 提取 25.0-80.0 U/mL 4 总胆汁酸(TBA) 酶循环法 提取 4.00-19.00 mu;mol/L 5 二氧化碳(CO2) PEPC酶法 合成 10.0-20.0 mmol/L 6 乳酸(LAC) 乳酸氧化酶法 合成 1.00-2.20 mmol/L 7 游离脂肪酸(NEFA) ACS-ACOD法 合成 0.200-0.500 mmol/L 批特异，具体浓度见靶值单。
2°C~8°C Protected from light and stored in a closed manner, effective
2℃～8℃避光密闭保存，有效