Stiffman GADI + GADII IgG Dot for BDI

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

Stiffman GADI + GADII IgG Dot for BDI

Code d'UDI-DI

05425023687444

Basic UDI-DI

542502368BDDGADYB

Numéro de référence/catalogue

AD GADBD

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

This kit 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 D-tek’s GADIV-24 is for the detection of Stiffman Syndrome only. The test is intended for a large, routine population. This kit is strictly reserved for professional use in clinical analysis laboratories. This kit is strictly foreseen as an automated test and can only be used in a BlueDiver Instrument Model I or II (hereinafter named BDI I or BDI II respectively). Detection of the different IgG autoantibodies can be either qualitative or semi-quantitative. For a semi-quantification of the test results, it is necessary to use the BlueScan scanner system and the Dr Dot software. This system is not included in the BDI I but is included in the BDI II.

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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