Hepatitis B Virus Pre-S1 Antigen Test Kit (Chemiluminescence Magnetic Microparticle 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20243400501
- Approval date
- March 13, 2024
- Expiry date
- March 12, 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，12号3层西，12号1层西侧
It is used for in vitro qualitative detection of hepatitis B virus pre-S1 antigen in human serum or plasma samples.
用于体外定性检测人体血清或血浆样本中的乙型肝炎病毒前S1抗原。
Reagent Pack, Pre-S1 Control 1, Pre-S1 Control 2, Information Card. (Please refer to the manual for details)
试剂包、Pre-S1 对照品1、Pre-S1 对照品2、信息卡。（具体内容详见说明书）
2 °C ~ 8 °C storage, valid for 12 months.
2℃~8℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Hepatitis B Virus Pre-S1 Antigen Test Kit (Chemiluminescence Magnetic Microparticle 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20243400501 and owned by Beijing BGI-GBI Biotech Co., Ltd.. The device was approved on March 13, 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.