Cardiac Troponin I (cTnI) Detection Reagent Kit (Magnetic Particle Chemiluminescence Method) - NMPA Registration 湘械注准20242401054
Access comprehensive regulatory information for Cardiac Troponin I (cTnI) Detection Reagent Kit (Magnetic Particle 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 湘械注准20242401054 and owned by Hunan Yonghe-sun Biotechnology Co., Ltd.. The device was approved on October 31, 2024.
This page provides complete registration details including registrant information, province location (Hunan), 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.
用于体外定量检测血清、血浆及全血中心肌肌钙蛋白I的含量.临床上主要用于心肌梗死的辅助诊断.
用于体外定量检测血清、血浆及全血中心肌肌钙蛋白I的含量。临床上主要用于心肌梗死的辅助诊断。
产品由试剂R1、试剂R2、校准品、质控品组成.磁分离试剂R1:包被着cTnI抗体的超顺磁性微粒,0.2g/L;Tris缓冲液,50mmol/L;ProClin 300,0.5g/L;试剂R2:cTnI 抗体-吖啶酯标记物,3 mg/L;PBS 缓冲液,50mmol/L;ProClin 300,0.5 g/L;校准品:cTnI 抗原、海藻糖、PBS,水平 1:0ng/mL、水平2:(0.1-1.0)ng/mL、水平3:(20.0-30.0)ng/mL;质控品:cTnI 抗原、海藻糖、PBS,水平 1:(1.0-2.0)ng/mL、水平2:(10-20)ng/mL.
产品由试剂R1、试剂R2、校准品、质控品组成。磁分离试剂R1:包被着cTnI抗体的超顺磁性微粒,0.2g/L;Tris缓冲液,50mmol/L;ProClin 300,0.5g/L;试剂R2:cTnI 抗体-吖啶酯标记物,3 mg/L;PBS 缓冲液,50mmol/L;ProClin 300,0.5 g/L;校准品:cTnI 抗原、海藻糖、PBS,水平 1:0ng/mL、水平2:(0.1-1.0)ng/mL、水平3:(20.0-30.0)ng/mL;质控品:cTnI 抗原、海藻糖、PBS,水平 1:(1.0-2.0)ng/mL、水平2:(10-20)ng/mL。
未开封的试剂在2℃～8℃条件下保存,有效期为18个月;开封后的试剂在2℃～8℃条件下保存,有效期为1个月.未开封校准品、质控品在2℃～8℃条件下避光保存,有效期为18个月;校准品、质控品复溶后,避光2℃～8℃条件下,可稳定3天.
未开封的试剂在2℃～8℃条件下保存，有效期为18个月；开封后的试剂在2℃～8℃条件下保存，有效期为1个月。未开封校准品、质控品在2℃～8℃条件下避光保存，有效期为18个月；校准品、质控品复溶后，避光2℃～8℃条件下，可稳定3天。