Digoxin determination reagent kit (chemiluminescence method) - NMPA Registration 苏械注准20252400096
Access comprehensive regulatory information for Digoxin determination reagent kit (chemiluminescence method) 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20252400096 and owned by Suzhou Evermed Biomedical Co., Ltd.. The device was approved on January 17, 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地高辛的含量。
试剂R1：包被鼠抗地高辛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：地高辛-碱性磷酸酶缀合物≥20U/L、Tris缓冲液≥10 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%、地高辛（化学合成）：水平1：（0.150~0.650）ng/mL（终液pH 6.5-7.5）水平2：（0.700~2.600）ng/mL（终液pH 6.5-7.5）水平3：（3.000~6.000）ng/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%、地高辛（化学合成）：（0.560~1.040）ng/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%、地高辛（化学合成）：（1.120~2.080）ng/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%、地高辛（化学合成）：（2.240~4.160）ng/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；校准品、质控品密闭贮存于2℃~8℃，有效期为15个月；试剂、校准品、质控品开封后在2℃~8℃密闭贮存环境下，有效期为30天。