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Leucine aminopeptidase assay kit (L-leucyl-p-nitroaniline substrate method) - NMPA Registration 京械注准20232400607

Access comprehensive regulatory information for Leucine aminopeptidase assay kit (L-leucyl-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20232400607 and owned by Beijing Homa Biological Engineering Co., Ltd.. The device was approved on September 27, 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20232400607
Leucine aminopeptidase assay kit (L-leucyl-p-nitroaniline substrate method)
亮氨酸氨基肽酶测定试剂盒 (L-亮氨酰-p-硝基苯胺底物法)
NMPA Registration Number: 京械注准20232400607
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Intended Use
English

This kit is used for the in vitro quantitative determination of the concentration of leucine aminopeptidase (LAP) in human serum.

中文

本试剂盒用于体外定量测定人血清中亮氨酸氨基肽酶(LAP)的浓度。

Device Classification
Device Class
Class II
Model Specifications
Reagent 1:1; 45ml; Reagent 2:1; 15ml Reagent 1:2; 45ml; Reagent 2:2; 15ml Reagent 1:1; 60ml; Reagent 2:1; 20ml Reagent 1:2; 60ml; Reagent 2:2; 20ml Reagents 1:4; 60ml; Reagents 2:4; 20ml Reagent 1:1; 30ml; Reagent 2:1; 10ml Reagent 1:2; 30ml; Reagent 2:2; 10ml Reagent 1:3; 100ml; Reagent 2:1; 100ml Reagent 1: 3 L; Reagent 2: 1 L
试剂1:1;45ml;试剂2:1;15ml 试剂1:2;45ml;试剂2:2;15ml 试剂1:1;60ml;试剂2:1;20ml 试剂1:2;60ml;试剂2:2;20ml 试剂1:4;60ml;试剂2:4;20ml 试剂1:1;30ml;试剂2:1;10ml 试剂1:2;30ml;试剂2:2;10ml 试剂1:3;100ml;试剂2:1;100ml 试剂1:3L;试剂2:1L
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20232400607
Approval Date
September 27, 2023
Expiry Date
September 26, 2028
Registrant
Name
Beijing Homa Biological Engineering Co., Ltd.
北京豪迈生物工程股份有限公司
Province/Region
Beijing
北京
Address
East of the first and third floors of Building 7, No. 28 Yuhua Road, Linkong Economic Core Zone, Shunyi District, Beijing
北京市顺义区临空经济核心区裕华路28号7号楼一层、三层东侧
Production Facility
Production Address
北京市顺义区临空经济核心区裕华路28号7号楼一层、三层东侧
Structure and Composition
English

This reagent consists of reagent 1 (R1) and reagent 2 (R2). Reagent 1 (R1): HEPES buffer 50 mmol/L NaCL 100mmol/L TritonX-100 0.05% Sodium azide 1g/L Reagent 2 (R2): HEPES buffer 50 mmol/L L-Leucine-4-nitroaniline 15mmol/L Sodium azide 1g/L

中文

本试剂由试剂1(R1)和试剂2(R2)组成 试剂1(R1): HEPES缓冲液 50mmol/L NaCL 100mmol/L TritonX-100 0.05% 叠氮钠 1g/L 试剂2(R2): HEPES缓冲液 50mmol/L L-亮氨酸-4-硝基苯胺 15mmol/L 叠氮钠 1g/L

Storage Conditions and Expiration
English

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Additional Information
Appendix
产品技术要求、说明书