Cardiolipin/ ß2-GPI IgG 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

Cardiolipin/ ß2-GPI IgG Dot

Code d'UDI-DI

05425023687055

Basic UDI-DI

542502368BDAPS2U

Numéro de référence/catalogue

AD CBGD

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 Cardiolipin/ß2-GPI complex (CL/ß2-GPI) and ß2-GPI (isolated protein) antigens.This kit is intended to confirm results of patterns obtained by Enzyme Immunoassay techniques; the kit is intended as an aid in the diagnosis of several autoimmune diseases (for more details, see 11.5 of IFU Auto-antibodies diagnostic values).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.

• W0102100599ANTI-PHOSPHOLIP SYNDROME - OTHER

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