Hepatitis E Virus IgM Antibody Test Kit (Magnetic Microparticle Chemiluminescence Method) - NMPA Registration 国械注准20243402356
Access comprehensive regulatory information for Hepatitis E Virus IgM Antibody Test Kit (Magnetic Microparticle Chemiluminescence Method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243402356 and owned by Beijing BGI-GBI Biotech Co., Ltd.. The device was approved on November 21, 2024.
This page provides complete registration details including registrant information, province location (Beijing), 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.
用于体外定性检测人体血清或血浆样本中的戊型肝炎病毒IgM抗体.
用于体外定性检测人体血清或血浆样本中的戊型肝炎病毒IgM抗体。
试剂包(包括包被鼠抗人IgM μ链单克隆抗体的磁珠(M)、吖啶酯标记的HEV重组抗原(R2)、反应稀释液(R3));HEV IgM对照品1;HEV IgM对照品2和信息卡.(具体内容详见产品说明书)
试剂包（包括包被鼠抗人IgM μ链单克隆抗体的磁珠（M）、吖啶酯标记的HEV重组抗原（R2）、反应稀释液（R3））；HEV IgM对照品1；HEV IgM对照品2和信息卡。（具体内容详见产品说明书）
2 °C ~ 8 °C storage, valid for 12 months.
2℃~8℃保存，有效期12个月。