霉酚酸测定试剂盒（化学发光法） - NMPA Registration 苏械注准20252400110
Access comprehensive regulatory information for 霉酚酸测定试剂盒（化学发光法） in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20252400110 and owned by Suzhou Evermed Biomedical Co., Ltd.. The device was approved on January 21, 2025.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.
用于体外定量检测人体血清或血浆中霉酚酸的含量。
试剂R1：包被鼠抗霉酚酸单克隆抗体的磁性微粒≥0.1 mg/mL、Tris缓冲液≥10 mmol/L、防腐剂（普瑞克宁300）0.05%（终液pH 6.0-9.0）试剂R2：霉酚酸-碱性磷酸酶缀合物≥20U/L、Tris缓冲液≥10mmol/L、防腐剂（普瑞克宁300）0.05%（终液pH 6.0-9.0）试剂R3：NaCl缓冲液≥50 mmol/L、防腐剂（普瑞克宁300）0.05%（终液pH 6.0-9.0）校准品：Tris缓冲液50 mmol/L、牛血清白蛋白0.25%、防腐剂（普瑞克宁300）0.05%、霉酚酸（化学合成）：水平1：（1.00~3.00）μg/mL（终液pH 6.5-7.5）水平2：（4.00~12.00）μg/mL（终液pH 6.5-7.5）水平3：（16.00~38.00）μg/mL（终液pH 6.5-7.5）质控品1：Tris缓冲液50 mmol/L、牛血清白蛋白0.25%、防腐剂（普瑞克宁300）0.05%、霉酚酸（化学合成）：（2.10~3.90）μg/mL（终液pH 6.5-7.5）质控品2：Tris缓冲液50 mmol/L、牛血清白蛋白0.25%、防腐剂（普瑞克宁300）0.05%、霉酚酸（化学合成）：（4.20~7.80）μg/mL（终液pH 6.5-7.5）质控品3：Tris缓冲液50 mmol/L、牛血清白蛋白0.25%、防腐剂（普瑞克宁300）0.05%、霉酚酸（化学合成）：（8.40~15.60）μg/mL（终液pH 6.5-7.5）
试剂密闭贮存于2℃~8℃、不可冷冻，有效期为15个月；试剂开封后在2℃~8℃密闭贮存环境下，有效期为30天；校准品、质控品密闭贮存于-20℃，有效期为15个月，密闭贮存于2℃~8℃，有效期为1个月，反复冻融不得超过3次，复融开封后2℃~8℃可稳定1个月。