Gamma-GT (IFCC)

Nom de l'organisation

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Statut du fabricant

Actif

Marché principal en Finlande ; disponible dans 28 pays au total.

Dénomination commerciale

Gamma-GT (IFCC)

Code d'UDI-DI

16438153817786

Basic UDI-DI

6438153BU00161BS

Numéro de référence/catalogue

981778

Entité d'attribution

GS1

Catégorie de risque

IVDR Classe B

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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.

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Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W01010116GAMMA GLUTAMYLTRANSFERASE

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• Date d'expiration
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