Cardiolipin/β2- GPI IgG 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

Cardiolipin/β2- GPI IgG for BDI

Code d'UDI-DI

05425023687352

Basic UDI-DI

542502368BDDAPSZQ

Numéro de référence/catalogue

AD CBGDBD

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. 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 IFU), either semi-quantitative (see point 10.2 of 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 IFU).

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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