抗β2糖蛋白1抗体IgM测定试剂盒(直接化学发光法) - NMPA Registration 川械注准20242400327
Access comprehensive regulatory information for 抗β2糖蛋白1抗体IgM测定试剂盒(直接化学发光法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 川械注准20242400327 and owned by Maccura Biotechnology Co., Ltd.. The device was approved on December 04, 2024.
This page provides complete registration details including registrant information, province location (Sichuan), 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.
本品用于体外定量测定人血清或血浆样本中抗β2糖蛋白1抗体IgM的浓度.
本品用于体外定量测定人血清或血浆样本中抗β2糖蛋白1抗体IgM的浓度。
试剂盒包含试剂1(R1):β2糖蛋白1(1.0～4.0)μg/mL、磁微粒(0.2～0.8)mg/mL;试剂2(R2):吖啶酯标记的鼠抗人IgM抗体(0.02～0.2)μg/mL;试剂3(R3):磷酸盐缓冲液;校准1(Cal1):含抗β2糖蛋白1抗体IgM;校准2(Cal2):含抗β2糖蛋白1抗体IgM;水平1(QC1): 含抗β2糖蛋白1抗体IgM;水平2(QC2): 含抗β2糖蛋白1抗体IgM.(具体内容详见产品说明书)
试剂盒包含试剂1（R1）：β2糖蛋白1（1.0～4.0）μg/mL、磁微粒（0.2～0.8）mg/mL；试剂2（R2）：吖啶酯标记的鼠抗人IgM抗体（0.02～0.2）μg/mL；试剂3（R3）：磷酸盐缓冲液；校准1（Cal1）：含抗β2糖蛋白1抗体IgM；校准2（Cal2）：含抗β2糖蛋白1抗体IgM；水平1（QC1）: 含抗β2糖蛋白1抗体IgM；水平2（QC2）: 含抗β2糖蛋白1抗体IgM。（具体内容详见产品说明书）
本品于2℃～8℃密闭避光保存,有效期为18个月,避免冷冻.
本品于2℃～8℃密闭避光保存，有效期为18个月，避免冷冻。