Hepatitis E Virus IgM Antibody Test Kit (Magnetic Microparticle Chemiluminescence Method)
- Device class
- Class III
- Model specifications
- 100 servings/box100人份/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243402356
- Approval date
- November 21, 2024
- Expiry date
- November 20, 2029
- Name
- Beijing BGI-GBI Biotech Co., Ltd.北京华大吉比爱生物技术有限公司
- Province/Region
- Beijing北京
- Address
- Room 236, Room 237, Building 1, No. 538, Yongfeng Tun, Haidian District, Beijing北京市海淀区永丰屯538号1号楼236、237室
- Production address
- 北京市顺义区临空经济核心区裕华路28号6号4层，8号2层西侧，8号楼2层东侧，12号1层西侧，12号3层西，12号楼3层东侧
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。
- Changes
- 2024-12-03 生产地址由:北京市顺义区临空经济核心区裕华路28号6号4层，8号2层西侧，12号3层西，12号1层西侧; 生产地址变更为:北京市顺义区临空经济核心区裕华路28号6号4层，8号2层西侧，8号楼2层东侧，12号1层西侧，12号3层西，12号楼3层东侧
- Appendix
- 产品技术要求、说明书
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.