Alpha-fetoprotein detection test kit (latex immunoturbidimetric method)
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243401408
- Approval date
- August 05, 2024
- Expiry date
- August 04, 2029
- Name
- Beijing Bioassay Technologies Corporation北京世纪沃德生物科技有限公司
- Province/Region
- Beijing北京
- Address
- 401, 4th floor, 4th floor, No. 21, Torch Street, Science and Technology Park, Changping District, Beijing北京市昌平区科技园区火炬街21号4幢4层401
- Production address
- 北京市昌平区火炬街28号1号楼一层东侧；北京市中关村科技园昌平园火炬街28号1号楼一层西侧B区
This product is used for the quantitative determination of alpha-fetoprotein (AFP) content in human serum and plasma in vitro. Clinically, it is mainly used for dynamic monitoring of patients with malignant tumors to assist in judging the disease process or treatment effect, and cannot be used as the basis for early diagnosis or diagnosis of malignant tumors, and is not used for tumor screening in the general population.
本产品用于体外定量测定人血清、血浆中甲胎蛋白（AFP）的含量。临床上主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不用于普通人群的肿瘤筛查。
Reagent 1, Reagent 2, calibrator and quality control. (Please refer to the product manual for details)
试剂1、试剂2、校准品和质控品。（具体内容详见产品说明书）
Store at 2°C~8°C in the dark, valid for 18 months.
2℃～8℃避光保存，有效期为18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Alpha-fetoprotein detection test kit (latex immunoturbidimetric 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20243401408 and owned by Beijing Bioassay Technologies Corporation. The device was approved on August 05, 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.