9.038.XXX.YY.ZZZ

Nom de l'organisation

OPERON, S.A.

SRN

ES-MF-000004790

Statut du fabricant

Actif

Marché principal en Espagne ; disponible dans 6 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-84295779038Y2GY

Basic UDI-DI

B-84295779038Y2GY

Numéro de référence/catalogue

9.038.XXX.YY.ZZZ

Entité d'attribution

EUDAMED

Catégorie de risque

IVDD — Général

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

OPERON's 2A-Bdiff chromatographic immunoassay provides a procedure for a qualitative detection of Clostridium difficile toxin A (TcdA) and toxin B (TcdB) in two separate bands. A positive band of either toxin is a sign of an underlying Clostridium difficile infection (CDI), which should be taken into consideration by the clinician. Unlike other immunoassay systems (ELISA and rapid tests) that only allow detection of TcdA and TcdB in combination and without any differentiation between the two, the OPERON 2A-Bdiff test allows you to run a single assay with a single strip that differentiates between both of the toxins using two separated bands - a red band below the blue control band when TcdA is present, and another red band above the control band when TcdB is in the sample (see Fig. 1). The test is based on the immunological capture of coloured microparticles during their passage along a membrane on which specific monoclonal antibodies against TcdA and TcdB have been immobilised at two separated locations.

URL des informations complémentaires

https://www.operondx.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0105090106CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC

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