ALT / GPT (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

ALT / GPT (IFCC)

UDI-DI code

16438153813610

Basic UDI-DI

6438153BU00157C3

Reference / catalog number

981361

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 alanine aminotransferase (L-Alanine: 2-Oxoglutarate Aminotransferase (ALT), EC 2.6.1.2) activity in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The ALT/GPT test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of parenchymal liver diseases associated with hepatic necrosis, such as acute hepatitis, including viral hepatitis and cirrhosis, in patients. Furthermore, the ALT/GPT test is also indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of chronic hepatitis, if increased ALT activity is persisting for a longer time, after acute hepatitis, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010103ALANINE AMINO-TRANSFERASE

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