BlueDiverDot ANCA+GBM 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

BlueDiverDot ANCA+GBM IgG

Code d'UDI-DI

05425023681350

Basic UDI-DI

542502368BDDANCA4F

Numéro de référence/catalogue

ANCAGDIV-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

BlueDiver Dot ANCA+GBM IgG is an Immunodot kit intended for the detection, in human sera only, of IgG autoantibodies against the following antigens : MPO, PR3 and GBM. This kit is intended to confirm results of patterns obtained by immunofluorescence, the screening and reference method in autoimmunity; the kit is intended as an aid in the diagnosis of several autoimmune diseases. 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 auto-antibodies can be either qualitative (see point 10.1 of the IFU), either semi-quantitative (see point 10.2 of the IFU). 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 (see point 4 of the IFU).

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0102100401ANCA SCREENING

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