DIASpot Neptune ANA8 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

DIASpot Neptune ANA8 IgG

Code d'UDI-DI

05425023688106

Basic UDI-DI

542502368BDDANAYE

Numéro de référence/catalogue

KAPDTANA8N

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 the following antigens: Sm, Sm/RNP, SSA/Ro 60kD, SSB, Jo-1, Scl-70, PM-Scl 100 and CENP-A/B. This kit is intended to confirm results of anti-nuclear 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 Neptune Instrument. Detection of the different IgG auto-antibodies can be either qualitative, either semi-quantitative. 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 Neptune Instrument.

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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