β2-microglobulin calibration material - NMPA Registration 吉械注准20252400039
Access comprehensive regulatory information for β2-microglobulin 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 吉械注准20252400039 and owned by Dirui Industrial Co., Ltd.. The device was approved on January 14, 2025.
This page provides complete registration details including registrant information, province location (Jilin), 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.
本产品与本公司β2-微球蛋白测定试剂盒（胶乳免疫比浊法）配套使用，用于临床检验实验室定量测定人血清、血浆、尿液样本β2-微球蛋白项目的系统校准。
型号A（适用于血清、血浆）： β2-微球蛋白（水平1：0mg/L～0.2mg/L，水平2：1.5mg/L～4.4mg/L，水平3：4.5mg/L～8.8mg/L，水平4：9mg/L～15mg/L，水平5：18mg/L～26mg/L）、三（羟甲基）氨基甲烷缓冲液≥5mmol/L、Proclin 300≥0.04%。 型号B（适用于尿液）： β2-微球蛋白（水平1：0mg/L～0.2mg/L，水平2：0.3mg/L～0.89mg/L，水平3：0.9mg/L～1.6mg/L，水平4：1.7mg/L～2.9mg/L，水平5：3.4mg/L～5.5mg/L）、三（羟甲基）氨基甲烷缓冲液≥5mmol/L、Proclin 300≥0.04%。