9.108.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-84295779108XWJT

Basic UDI-DI

B-84295779108XWJT

Numéro de référence/catalogue

9.108.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

One-step immunochromatographic test to aid in a rapid diagnosis of bacterial pneumonia caused by Streptococcus pneumoniae and Legionella pneumophila serogroup 1 by means of detecting their urinary antigens in human urine. A positive result on either of the test lines gives a good indication of a current or previous infection by S. pneumoniae and/or L. pneumophila serogroup 1. In the event of a patient showing the common symptoms of this type of infection but a negative test result, confirming the result with a respiratory sample culture, a blood culture, or using PCR molecular techniques is recommended. The results of this test is intended to aid to diagnosis an infection from Streptococcus pneumoniae and/or L. pneumophila serogrupo 1, also considering data derived from a clinical evaluation of the patient; the test does not constitute a definitive diagnosis in itself. 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. It is a professional use only product. It is not a device for near-patient testing. It is not a device self-testing.

URL des informations complémentaires

https://www.operondx.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0105090199BACTERIOLOGY - RT & POC - OTHER

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