9.041.XXX.YY.ZZZ

Nom de l'organisation

OPERON, S.A.

SRN

ES-MF-000004790

Statut du fabricant

Actif

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-84295779041XPHT

Basic UDI-DI

B-84295779041XPHT

Numéro de référence/catalogue

9.041.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

A single-step qualitative immunochromatographic test to aid in the diagnosis of the gastrointestinal infection caused by Norovirus by means of the detection in separate bands of genogroup I (GI) and genogroup II (GII) in human stools. A positive signal on either of the positive test lines gives a good indication that a Norovirus infection may be present, which should help with the patient’s diagnosis. The test results should not be used as the only criterion for diagnosing this infection. A doctor should evaluate them in combination with other clinical information about the patient. The test is qualitative and its execution is not automated, although the results interpretation can be done visually or by using a strip reader. This test is exclusively for in vitro diagnostic use. This test is for professional use. This is not a diagnostic test for use at the patient care location. This is not a self-diagnostic test.

URL des informations complémentaires

https://www.operondx.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0105099099VIROLOGY - RT & POC - OTHER

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