肌酸激酶同工酶检测试剂盒(化学发光微粒子免疫检测法) - NMPA Registration 冀械注准20242400408
Access comprehensive regulatory information for 肌酸激酶同工酶检测试剂盒(化学发光微粒子免疫检测法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 冀械注准20242400408 and owned by Hebei Archi Biological Technology Co., Ltd.. The device was approved on November 01, 2024.
This page provides complete registration details including registrant information, province location (Hebei), 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中肌酸激酶同工酶(CK-MB)的含量.
用于体外定量检测人体血清中肌酸激酶同工酶（CK-MB）的含量。
M试剂:CK-MB抗体包被的微粒子固相物(0.5mg/mL),存贮于含有蛋白(牛)稳定剂的磷酸盐(50.0mmol/L)缓冲液中;防腐剂. R试剂:吖啶酯标记的CK-MB抗体结合物(0.5μg/mL),存贮于含有蛋白(牛)稳定剂的磷酸盐(50.0mmol/L)缓冲液中;防腐剂. 校准品:适量的CK-MB存贮于含有蛋白(牛)稳定剂的磷酸盐(50.0mmol/L)缓冲液;防腐剂. 质控品:适量的CK-MB存贮于含有蛋白(牛)稳定剂的磷酸盐(50.0mmol/L)缓冲液;防腐剂. CK-MB包被抗体和CK-MB标记抗体均为小鼠单克隆抗体,CK-MB抗原为重组抗原.
M试剂：CK-MB抗体包被的微粒子固相物（0.5mg/mL），存贮于含有蛋白（牛）稳定剂的磷酸盐（50.0mmol/L）缓冲液中；防腐剂。 R试剂：吖啶酯标记的CK-MB抗体结合物（0.5μg/mL），存贮于含有蛋白（牛）稳定剂的磷酸盐（50.0mmol/L）缓冲液中；防腐剂。 校准品：适量的CK-MB存贮于含有蛋白（牛）稳定剂的磷酸盐（50.0mmol/L）缓冲液；防腐剂。 质控品：适量的CK-MB存贮于含有蛋白（牛）稳定剂的磷酸盐（50.0mmol/L）缓冲液；防腐剂。 CK-MB包被抗体和CK-MB标记抗体均为小鼠单克隆抗体，CK-MB抗原为重组抗原。
Kits, calibrators, and controls are stable for 18 months when stored at 2-8°C.
试剂盒、校准品和质控品于2-8℃保存可稳定18个月。