3.154.XXX.YY.ZZZ

Nom de l'organisation

OPERON, S.A.

SRN

ES-MF-000004790

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW265

  The denaturation solution contains < 2% NaOH

Marché principal en Espagne ; disponible dans 8 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-84295773154WTGK

Basic UDI-DI

B-84295773154WTGK

Numéro de référence/catalogue

3.154.XXX.YY.ZZZ

Entité d'attribution

EUDAMED

Catégorie de risque

IVDD — Annexe II Liste B

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

TENDED USE The HLA B*27 Strip test allows the determination of the HLA B*27 allele. This group of alleles has been associated with a wide range of pathologies such as ankylosing spondylitis (88-95% of patients), acute anterior uveitis (50-60% of patients), reactive arthritis (60-85% of patients), and inflammatory bowel disease (50-60% of patients). This test is only a tool to help the professionals in the diagnosis of the indicated pathologies. This kit cannot be the only diagnosis tool. The Major Histocompatibility System comprises a set of genes, most of them highly polymorphic, whose products are expressed in a wide range of cells and are responsible for the ‘adaptive’ immune response. These genes are present in all vertebrates and, in humans, they are known as the HLA (Human Leukocyte Antigen) system. The proteins encoded by these genes are called ‘HLA molecules’ or ‘HLA antigens’. The existence of a genetic predisposition to various diseases in individuals carrying the HLA-B*27 histocompatibility antigen has been demonstrated: ankylosing spondylitis, acute anterior uveitis, reactive arthritis, inflammatory bowel disease.

URL des informations complémentaires

https://www.operondx.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0106010401HLA-TYPING

• Numéro de lot
• Date d'expiration
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