Alanine aminotransferase assay kit (alanine substrate method)
- 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 number
- 京械注准20242400729
- Approval date
- November 26, 2024
- Expiry date
- November 25, 2029
- 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 address
- 北京市怀柔区雁栖经济开发区雁栖北二街15号
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.
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。
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
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
试剂盒在2℃~ 8℃密封避光保存,有效期12个月.
试剂盒在2℃~ 8℃密封避光保存，有效期12个月。
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.