Gamma-GT (IFCC)

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

Primary placement in Finland; available across 28 countries total.

Trade name

Gamma-GT (IFCC)

UDI-DI code

16438153813771

Basic UDI-DI

6438153BU00161BS

Reference / catalog number

981377

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010116GAMMA GLUTAMYLTRANSFERASE

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