Gamma-GT (IFCC)

Primary DI

16438153813771

Basic UDI-DI Code

6438153BU00161BS

Reference

981377

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Thermo Fisher Scientific Oy

INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of Gamma-GT (γ-Glutamyltransferase (GGT), EC 2.3.2.2) activity in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Gamma-GT test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of hepatobiliary diseases, in patients. The Gamma-GT test is furthermore indicated to be used in conjunction with clinical evaluation for aid to diagnosis, screening and monitoring of various diseases, injuries and clinical disorders of the liver, such as primary or secondary liver neoplasms or alcoholic hepatitis, in patients. The Gamma-GT test is also indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of acute and chronic pancreatitis and pancreatic malignancies (in particular if associated with hepatobiliary obstruction), in patients. Furthermore, the Gamma-GT test is indicated to be used in conjunction with clinical evaluation for the detection and monitoring of the effects of hepatotoxins (chemicals, organic solvents) and drug intoxications (paracetamol, anticonvulsant drugs including carbamazepin, phenytoin and phenobarbital), in patients.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).