BILE ACIDS

Primary DI

D-02B0014YL

Basic UDI-DI Code

B-02B0014YL

Reference

1Y001

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Changsha Sinocare Inc.

The Total Bile Acid/Cholinesterase/α-Amylase Reagent Kit is intended to quantitatively determine total bile acid (TBA), and measure the activity of cholinesterase (CHE) and α-amylase (α-AMY) in human vein serum. Clinically, it is mainly used as an aid in the diagnosis of hepatobiliary diseases or injuries, organophosphorus intoxication and pancreatic diseases. Total bile acid (TBA) is the end product of cholesterol metabolism in liver and is existed in the enterohepatic circulation. It is closely related to the absorption, metabolism and adjustment of cholesterol. Serum TBA is a relatively sensitive diagnose indicator for substantial liver injury and digestive system diseases. TBA specifically reflects the excretory function of liver, as TBA elevates once there are hepatic cell lesion or enterohepatic circulation disorder. CHE is a glycoprotein which exists in human body in form of several isozymes. The measuring of CHE activity is an important method that helps to diagnose organophosphorus intoxication and evaluate substantial liver injury. α-AMY is mainly secreted by sialaden and pancreas, and can be filtered by glomerulus. Currently, the detection of α-AMY is the main method of diagnosing pancreatitis.

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