α-突触核蛋白(α-synuclein)测定试剂盒（磁微粒化学发光法） - NMPA Registration 湘械注准20252400013
Access comprehensive regulatory information for α-突触核蛋白(α-synuclein)测定试剂盒（磁微粒化学发光法） in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20252400013 and owned by Hunan Yonghe-sun Biotechnology Co., Ltd.. The device was approved on January 03, 2025.
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.
用于体外定量检测人体血清和血浆样本中的α-突触核蛋白含量。
产品由试剂R1、试剂R2、校准品、质控品组成。磁分离试剂R1:包被有α-突触核蛋白抗体的磁性微粒(约0.07μg/mL);ProClin 300,约 0.5g/L;试剂 R2:α-突触核蛋白抗体-吖啶酯标记物,约3μg/mL;ProClin 300,约 0.5 g/L;校准品: α-突触核蛋白抗原、PBS,水平1:0 pg/mL、水平2:(300-1500)pg/mL、水平3:(5000-20000)pg/mL;质控品:α-突触核蛋白抗原、PBS, 水平 1:(300-1500)pg/mL、水平2:(5000-20000)pg/mL。
未开封的试剂 2℃～8℃条件下避光保存，有效期为18个月；开封后，2℃～8℃避光保存可稳定30天。未开封的校准品、质控品 2℃～8℃条件下避光保存，有效期为18个月；开封后，校准品、质控品复溶后2℃～8℃条件下保存，24小时内使用。