ALANINE AMINO-TRANSFERASE

Primary DI

D-02B0004YH

Basic UDI-DI Code

B-02B0004YH

Reference

1F001

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Changsha Sinocare Inc.

The Alanine Aminotransferase/Aspartate Aminotransferase/Total Bilirubin/Albumin Reagent Kit is intended to quantitatively determine the activity of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and concentration of total bilirubin (TB) and albumin (ALB) concentration in human serum. Clinically, it is mainly used for auxiliary diagnosis of liver diseases. ALT and AST are sensitive indicators of liver cell damage and liver injury degree. The AST concentration elevates continuously and goes beyond ALT concentration usually indicates severe liver damage and is a sign of aggravation of chronic disease. TB is the total value of direct bilirubin and indirect bilirubin. Clinically, it is mainly used to diagnose whether the liver disease or biliary tract is in abnormal state. ALB is produced by liver. When there is severe hepatosis (such as liver cirrhosis), liver’s ability to produce albumin is greatly decreased, resulting in the decrease of serum albumin concentration.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).