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Alanine aminotransferase assay kit (alanine substrate method) - NMPA Registration 京械注准20242400729

Access comprehensive regulatory information for Alanine aminotransferase assay kit (alanine 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20242400729 and owned by Beijing Strong Biotechnologies,Inc.. The device was approved on November 26, 2024.

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20242400729
Alanine aminotransferase assay kit (alanine substrate method)
丙氨酸氨基转移酶测定试剂盒(丙氨酸底物法)
NMPA Registration Number: 京械注准20242400729
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Intended Use
English

本试剂盒用于体外定量测定人血清中丙氨酸氨基转移酶(谷丙转氨酶,ALT)含量.

中文

本试剂盒用于体外定量测定人血清中丙氨酸氨基转移酶(谷丙转氨酶,ALT)含量。

Device Classification
Device Class
Class II
Model Specifications
试剂1:2;55mL、试剂2:2;18mL;试剂1:2;51mL、试剂2:2;17mL;892测试/盒;830测试/盒.
试剂1:2;55mL、试剂2:2;18mL;试剂1:2;51mL、试剂2:2;17mL;892测试/盒;830测试/盒。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400729
Approval Date
November 26, 2024
Expiry Date
November 25, 2029
Registrant
Name
Beijing Strong Biotechnologies,Inc.
北京九强生物技术股份有限公司
Province/Region
Beijing
北京
Address
5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing
北京市海淀区花园东路15号旷怡大厦5层
Production Facility
Production Address
北京市怀柔区雁栖经济开发区雁栖北二街15号
Structure and Composition
English

试剂成分浓度试剂1:Goodrsquo;s缓冲液,pH9.0L-丙氨酸还原型辅酶I乳酸脱氢酶20mmol/L100mmol/L0.43mmol/L5KU/L试剂2:alpha;-酮戊二酸45mmol/L

中文

试剂成分浓度试剂1:Goodrsquo;s缓冲液,pH9.0L-丙氨酸还原型辅酶I乳酸脱氢酶20mmol/L100mmol/L0.43mmol/L5KU/L试剂2:alpha;-酮戊二酸45mmol/L

Storage Conditions and Expiration
English

试剂盒在2℃~ 8℃密封避光保存,有效期12个月.

中文

试剂盒在2℃~ 8℃密封避光保存,有效期12个月。