Amylase (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

Amylase (IFCC)

Code d'UDI-DI

16438153005220

Basic UDI-DI

6438153BU00061BM

Numéro de référence/catalogue

981950

Entité d'attribution

GS1

Catégorie de risque

IVDR Classe C

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 the α-amylase (1,4-α-D-glucan glucanohydrolase, EC 3.2.1.1) activity in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Amylase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of diseases of the pancreas, such as acute pancreatitis, in patients. Furthermore, the Amylase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of other clinical disorders, which are not specific to pancreatitis, such as salivary gland inflammation, acute intra-abdominal disorders or genitourinary diseases, in patients. For in vitro diagnostic use in the quantitative determination of the α-amylase (1,4-α-D-glucan glucanohydrolase, EC 3.2.1.1) activity in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Amylase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of diseases of the pancreas, such as acute pancreatitis, in patients. Furthermore, the Amylase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of other clinical disorders, which are not specific to pancreatitis, such as salivary gland inflammation, acute intra-abdominal disorders or genitourinary diseases, in patients.

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Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W01010107AMYLASE - TOTAL

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• Date d'expiration
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