China NMPA legacy archive 京械注准20232400328Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Reagent Kit (Latex Immunoturbidimetric Method)
脂蛋白磷脂酶A2（Lp-PLA2）测定试剂盒 (胶乳免疫比浊法)
Beijing Leadman Biochemistry Co., Ltd.Class IINMPAApproved May 15, 2023
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- Reagent 1 (R1): 2times; 60mL, Reagent 2(R2): 2times; 15mL; Reagent 1 (R1): 1times; 48mL, Reagent 2(R2): 1times; 12mL; Reagent 1 (R1): 2times; 48mL, Reagent 2(R2): 2times; 12mL; Reagent 1 (R1): 1times; 60mL, Reagent 2(R2): 1times; 12mL; Reagent 1 (R1): 1times; 60mL, Reagent 2(R2): 1times; 15mL; Reagent 1 (R1): 1times; 60mL, Reagent 2(R2): 1times; 20mL; Reagent 1 (R1): 1times; 32mL, Reagent 2(R2): 1times; 8mL; Reagent 1 (R1): 2times; 40mL, Reagent 2(R2): 2times; 10mL; Reagent 1 (R1): 1times; 40mL, Reagent 2(R2): 1times; 10mL; Reagent 1 (R1): 1times; 24mL, Reagent 2(R2): 1times; 6mL; Reagent 1 (R1): 1times; 20mL, Reagent 2(R2): 1times; 5mL; Reagent 1 (R1): 1times; 15mL, Reagent 2(R2): 1times; 5mL; Reagent 1 (R1): 1times; 16mL, Reagent 2(R2): 1times; 4mL; 256 Test/Box: (Reagent 1(R1): 1times; 41mL, Reagent 2 (R2): 1times; 11mL). Calibrator (optional): 1times; 1mL. Quality control (optional): 2times; 1mL.
- Approval department
- Beijing Municipal Drug Administration
试剂1（R1）：2times;60mL、 试剂2（R2）：2times;15mL； 试剂1（R1）：1times;48mL、 试剂2（R2）：1times;12mL； 试剂1（R1）：2times;48mL、 试剂2（R2）：2times;12mL； 试剂1（R1）：1times;60mL、 试剂2（R2）：1times;12mL； 试剂1（R1）：1times;60mL、 试剂2（R2）：1times;15mL； 试剂1（R1）：1times;60mL、 试剂2（R2）：1times;20mL； 试剂1（R1）：1times;32mL、 试剂2（R2）：1times;8mL； 试剂1（R1）：2times;40mL、 试剂2（R2）：2times;10mL； 试剂1（R1）：1times;40mL、 试剂2（R2）：1times;10mL； 试剂1（R1）：1times;24mL、 试剂2（R2）：1times;6mL； 试剂1（R1）：1times;20mL、 试剂2（R2）：1times;5mL； 试剂1（R1）：1times;15mL、 试剂2（R2）：1times;5mL； 试剂1（R1）：1times;16mL、 试剂2（R2）：1times;4mL； 256测试/盒：（试剂1（R1）：1times;41mL、试剂2（R2）：1times;11mL）。 校准品（选配）：1times;1mL。 质控品（选配）：2times;1mL。
北京市药品监督管理局
Registration information
- Registration number
- 京械注准20232400328
- Approval date
- May 15, 2023
- Expiry date
- May 14, 2028
Registrant
- Province/Region
- Beijing
- Address
- No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing
北京
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 lipoprotein phospholipase A2 (Lp-PLA2) content in human serum and plasma in vitro.
中文
本产品用于体外定量测定人血清和血浆中脂蛋白磷脂酶A2（Lp-PLA2）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 Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Reagent Kit (Latex Immunoturbidimetric Method), registration 京械注准20232400328. 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.