B Factor (BF) Assay Kit (Immune Turbidimetric Method)
- Device class
- Class II
- Model specifications
- Reagent (R): 2times; 80mL; Reagent (R): 2times; 60mL; Reagent (R): 3times; 400mL; Reagent (R): 1times; 20mL; Reagent (R): 1times; 30mL; Reagent (R): 1times; 60mL; Reagent (R): 2times; 100mL; Reagent (R): 2times; 15mL; Reagent (R): 5times; 15mL; Reagent (R): 10times; 15mL; Reagent (R): 20times; 15mL; 256 test/cassette: (Reagent (R): 77mL). Calibrator (optional): 1times; 1mL; 1times; 5mL. Quality control (optional): 1times; 1mL; 1times; 5mL.试剂（R）：2times;80mL；试剂（R）：2times;60mL； 试剂（R）：3times;400mL；试剂（R）：1times;20mL； 试剂（R）：1times;30mL；试剂（R）：1times;60mL； 试剂（R）：2times;100mL；试剂（R）：2times;15mL； 试剂（R）：5times;15mL；试剂（R）：10times;15mL； 试剂（R）：20times;15mL； 256测试/盒：（试剂（R）：77mL）。 校准品（选配）：1times;1mL；1times;5mL。 质控品（选配）：1times;1mL；1times;5mL。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232400329
- Approval date
- May 15, 2023
- Expiry date
- May 14, 2028
- Name
- Beijing Leadman Biochemistry Co., Ltd.北京利德曼生化股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing北京市北京经济技术开发区兴海路5号
- Production address
- 北京市北京经济技术开发区兴海路5号1幢2层、6层、B1层、2幢
This product is used for the quantitative determination of factor B (BF) content in human serum in vitro.
本产品用于体外定量测定人血清中B因子（BF）的含量。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for B Factor (BF) Assay Kit (Immune Turbidimetric Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20232400329 and owned by Beijing Leadman Biochemistry Co., Ltd.. The device was approved on May 15, 2023.
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.