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Leucine aminopeptidase (LAP) detection kit (L-leucine-p-nitroaniline substrate method) - NMPA Registration 京械注准20232400386

Access comprehensive regulatory information for Leucine aminopeptidase (LAP) detection kit (L-leucine-p-nitroaniline substrate 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20232400386 and owned by Beijing Leadman Biochemistry Co., Ltd.. The device was approved on June 20, 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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Class II
京械注准20232400386
Leucine aminopeptidase (LAP) detection kit (L-leucine-p-nitroaniline substrate method)
亮氨酸氨基转肽酶（LAP）测定试剂盒 （L－亮氨酸-p-硝基苯胺底物法）
NMPA Registration Number: 京械注准20232400386
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Intended Use
English

This product is used for the in vitro quantitative determination of leucine aminotransferpeptidase (LAP) content in human serum.

中文

本产品用于体外定量测定人血清中亮氨酸氨基转肽酶（LAP）的含量。

Device Classification
Device Class
Class II
Model Specifications
Reagent (R): 1times; 60mL; Reagent (R): 3times; 60mL; Reagent (R): 7times; 60mL; Reagent (R): 2times; 80mL; Reagent (R): 3times; 40mL; Reagent (R): 5times; 80mL; Reagent (R): 1times; 20mL; Reagent (R): 4times; 80mL; Reagent (R): 4times; 100mL; Reagent (R): 1times; 1000mL; Reagent (R): 1times; 5000mL; Reagent (R): 2times; 400mL; Reagent (R): 3times; 61mL; 1020 test/cassette: (Reagent (R): 3times; 60mL). Calibrator (optional): 1times; 1mL; 1times; 3mL. Quality control (optional): low value 1times; 1mL, high value 1times; 1mL; Low value 1times; 3mL, high value 1times; 3mL.
试剂（R）：1times;60mL；试剂（R）：3times;60mL； 试剂（R）：7times;60mL；试剂（R）：2times;80mL； 试剂（R）：3times;40mL；试剂（R）：5times;80mL； 试剂（R）：1times;20mL；试剂（R）：4times;80mL； 试剂（R）：4times;100mL；试剂（R）：1times;1000mL； 试剂（R）：1times;5000mL；试剂（R）：2times;400mL； 试剂（R）：3times;61mL； 1020测试/盒：(试剂（R）：3times;60mL)。 校准品（选配）： 1times;1mL；1times;3mL。 质控品（选配）：低值1times;1mL、高值1times;1mL； 低值1times;3mL、高值1times;3mL。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20232400386
Approval Date
June 20, 2023
Expiry Date
June 19, 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