Alanine Aminotransferase (ALT) Test Kit (IFCC)

Trade name

Alanine Aminotransferase (ALT) Test Kit (IFCC)

UDI-DI code

06971674862031

Basic UDI-DI

B-06971674862031

Reference / catalog number

R1:64mL×2 R2:16mL×2(701)

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

For the in vitro quantitative determination of the activity of alanine aminotransferase (ALT) in human serum or plasma. Alanine aminotransferase (ALT), also known as glutamic-pyruvic transaminase (GPT), has a relatively high concentration in the liver, while its content is low in the kidneys, heart, skeletal muscles, pancreas, spleen, and lungs. Generally, the elevation of ALT is caused by certain liver-related diseases, including viral or toxic hepatitis and obstructive jaundice; ALT elevation is also seen in conditions such as extensive injury, muscle diseases, circulatory failure accompanied by shock and oxygen deficiency, myocardial infarction, and hemolytic diseases. The determination of alanine aminotransferase activity holds important value for the auxiliary diagnosis of the aforementioned diseases. This test is a preliminary screening method and does not have the effectiveness of diagnosing diseases. It needs to be comprehensively judged in conjunction with other test results.The main methods used for alanine aminotransferase detection in clinical practice include the alanine substrate method, as well as the alanine substrate-pyruvate oxidase method and the 2,4-dinitrophenylhydrazine method.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01010103ALANINE AMINO-TRANSFERASE

No certificate specifically references this device's Basic UDI-DI.