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China NMPA legacy archive 京械注准20232400329

B Factor (BF) Assay Kit (Immune Turbidimetric Method)

B因子（BF）测定试剂盒（免疫比浊法）
Beijing Leadman Biochemistry Co., Ltd.Class IINMPAApproved May 15, 2023
Static archiveNMPA · legacy registration snapshot
Device classification
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 information
Registration number
京械注准20232400329
Approval date
May 15, 2023
Expiry date
May 14, 2028
Registrant
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 facility
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
Intended use
English

This product is used for the quantitative determination of factor B (BF) content in human serum in vitro.

中文

本产品用于体外定量测定人血清中B因子（BF）的含量。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for B Factor (BF) Assay Kit (Immune Turbidimetric Method), registration 京械注准20232400329. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.