5.237.XXX.88.ZZZ

Nom de l'organisation

OPERON, S.A.

SRN

ES-MF-000004790

Statut du fabricant

Actif

Marché principal en Espagne ; disponible dans 3 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-84295775237XEGW

Basic UDI-DI

B-84295775237XEGW

Numéro de référence/catalogue

5.237.XXX.88.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

The Real SARS CoV-2/Flu/RSV test is designed to detect and qualitatively differentiate the following viruses using the RT PCR Real Time method: coronavirus SARS-CoV1/2, Influenza virus (Flu A/B) and respiratory syncytial virus (RSV A/B), in samples from individuals with symptoms of infection in respiratory tracts. This involves using primers and probes that can amplify and detect a region of the E gene, specific to sarcovirus-type coronaviruses (SARS-CoV-1 and SARS-CoV-2), a region of the M gene, specific to Influenza viruses (Flu A/B), and a region of the N gene, specific to the respiratory syncytial viruses (RSV A/B). Real SARS CoV-2/Flu/RSV has been validated for use with respiratory samples, such as nasopharyngeal swabs, nasal swabs, oropharyngeal swabs, saliva and nasopharyngeal aspirates, as well as with nucleic acids extracted from those samples. The product is intended for specialised users as a means of support when diagnosing individuals suspected to have a viral respiratory infection. The clinical symptoms caused by the SARS-CoV-2, Influenza, and RSV viruses can be similar. The product can be used for any indication involved with virus detection: initial diagnosis, infection monitoring, and contact control. Take also under consideration other parameters such as symptoms or clinical history when giving the final diagnosis.

URL des informations complémentaires

https://www.operondx.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0105070304INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS

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