Vasculitis – ANCA + GBM Dot

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

Vasculitis – ANCA + GBM Dot

Code d'UDI-DI

05425023687192

Basic UDI-DI

542502368BDANCAYR

Numéro de référence/catalogue

AD MPGD

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 MPO, PR3 and GBM antigens. 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. 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 the IFU. 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) 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.

• W0102100401ANCA SCREENING

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel