Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Reagent Kit (Latex Immunoturbidimetric Method) - NMPA Registration 京械注准20232400328

Access comprehensive regulatory information for Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Reagent Kit (Latex Immunoturbidimetric 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20232400328 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.

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NMPA Official Data

Class II

京械注准20232400328

Lipoprotein-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)

NMPA Registration Number: 京械注准20232400328

DJ Fang

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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。

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.

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。

Approval Department

Beijing Municipal Drug Administration

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

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

Additional Information

Appendix

产品技术要求、说明书