BlueDot GAD IgG

Nom de l'organisation

D-tek s.a.

SRN

BE-MF-000024530

Statut du fabricant

Actif

Marché principal en Belgique ; disponible dans 17 pays au total.

Dénomination commerciale

BlueDot GAD IgG

Code d'UDI-DI

05425023680704

Basic UDI-DI

542502368BDGADZC

Numéro de référence/catalogue

GAD-24

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

BlueDot GAD IgG is an immunodot kit intended for the detection, in human sera only, of IgG autoantibodies against the antigens GAD I and GAD II. This kit is intended to confirm results obtained by Enzyme Immunoassay techniques; the kit is intended as an aid in the diagnosis of several autoimmune diseases. Please note that this kit is for the detection of the Stiffman Syndrome only. Detection of the different IgG autoantibodies can be either qualitative or semi-quantitative. The test is intended for a large, routine population. This kit is strictly reserved for professional use in clinical analysis laboratories. Prior training is strongly recommended (please contact your distributor). It can only be used manually on a platform shaker or in an open automated immunodot processing system, programmed according to the pipetting scheme described in point 9.2 of IFU. Detection of the different IgG auto-antibodies can be either qualitative (see point 10.1 of IFU), either semi-quantitative (see point 10.2 of IFU) when read on the BlueScan/DrDOT reading system.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0102100299NEURO-AUTO-IMMUNE DISEASE - OTHER

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