Creatine kinase isoenzyme (immunosuppressive) controls - NMPA Registration 京械注准20232400523
Access comprehensive regulatory information for Creatine kinase isoenzyme (immunosuppressive) controls 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20232400523 and owned by Beijing Enjihe Biological Engineering Co., Ltd.. The device was approved on August 29, 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.
The intrinsic control is used in conjunction with the creatine kinase isoenzyme assay kit (immunosuppressive method) produced by Lepu (Beijing) Diagnostic Technology Co., Ltd. for in-laboratory quality control of the creatine kinase isoenzyme (immunosuppressive method) project quantitative detection system in the clinical laboratory.
本质控品与乐普（北京）诊断技术股份有限公司生产的肌酸激酶同工酶测定试剂盒（免疫抑制法）配套使用，用于临床实验室肌酸激酶同工酶（免疫抑制法）项目定量检测系统的实验室内质量控制。
The essence control is a single-level lyophilized substance, bovine serum matrix, with the addition of project-specific bio-derived substances and chemical components. The specific items and target value ranges are shown in Table 1: Table 1 Main components serial number The name of the project methodology Target range U/L 1 Creatine kinase isoenzyme Immunosuppressive method 80.0～160.0 Controls are batch-specific, and concentrations are detailed in the target value sheet.
本质控品为单水平冻干品，牛血清基质，并添加了特定项目的生物源性物质和化学成分。具体项目及靶值范围见表1： 表1 主要组成成分 序号 项目名称 方法学 靶值范围 U/L 1 肌酸激酶同工酶 免疫抑制法 80.0～160.0 质控品具有批特异性，浓度详见靶值单。
2 °C ~ 8 °C sealed and protected from light, stable
2℃～8℃密封避光保存，可稳