Potassium Micro Volume Electrode

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

Potassium Micro Volume Electrode

Code d'UDI-DI

16438153815935

Basic UDI-DI

6438153BU00143BQ

Numéro de référence/catalogue

981593

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 potassium concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ analyzers, and in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Konelab™ analyzers. The Potassium Micro Volume Electrode test is indicated to be used in conjunction with clinical evaluation for screening and monitoring of electrolyte balance as part of a basic metabolic panel, in patients. Furthermore, the Potassium Micro Volume Electrode serum and plasma test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of decreased extracellular potassium levels (hypokalemia) and increased extracellular potassium levels (hyperkalemia), in patients. Disturbances of extracellular potassium levels can cause e.g. mental confusion, muscle weakness and neuromuscular disfunction, which can lead to severe cardiac symptoms. The Potassium Micro Volume Electrode test for urine is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of kidney disorders, and for evaluation the cause for hypo- and hyperkalemia, in patients.

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Dimensions cliniques

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• W0101070106POTASSIUM - ELECTRODES

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