Creatine kinase isoenzyme (immunosuppression method) calibration material - NMPA Registration 京械注准20232400524
Access comprehensive regulatory information for Creatine kinase isoenzyme (immunosuppression method) calibration material 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20232400524 and owned by Beijing Enjihe Biological Engineering Co., Ltd.. The device was approved on August 29, 2023.
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This calibrator is used in conjunction with the creatine kinase isoenzyme assay kit (immunosuppressive method) produced by Lepu (Beijing) Diagnostic Technology Co., Ltd. for the systematic calibration of the quantitative detection system of creatine kinase isoenzyme (immunosuppressive method) project in clinical laboratories.
本校准品与乐普（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系统校准。
This calibrator is a single-level lyophilized product, bovine serum matrix, and added with item-specific biogenic substances and chemical components. The specific projects and target ranges are shown in Table 1: Table 1 Main components serial number Project name methodology Target range U/L 1 Creatine kinase isoenzymes Immunosuppressive method 150.0～250.0 The calibrators are lot-specific, and the concentrations are detailed in the target list.
本校准品为单水平冻干品，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 150.0～250.0 校准品具有批特异性，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