ANA PROFILE 25 Ag 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

ANA PROFILE 25 Ag DOT for BDI

Code d'UDI-DI

05425023687604

Basic UDI-DI

542502368BDQANA3C

Numéro de référence/catalogue

AD ANA25DBD

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 Nucleosomes, dsDNA, Histones, Sm, RNP 68kD/A/C, Sm/RNP, SSA/Ro 60kD, SSA/Ro 52kD, SSB, Scl-70, Ku, PM-Scl 100, Mi-2, Jo-1, PL-7, PL-12, SRP-54, Ribosome P0, CENP-A/B, PCNA, sp100, gp210, M2 recombinant, M2/nPDC and F-Actin 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 confirmation of IFA positive population and IFA negative with strong suspicion of autoimmune disorder. 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 is semi-quantitative. For a semi-quantification of the test results, it is necessary to use the system BlueScan scanner/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.

• W0102100101ANA SCREENING

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