EBV/GP/025

Nom de l'organisation

GeneProof a.s.

SRN

CZ-MF-000002370

Statut du fabricant

Actif

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

• CW010

  EUDAMED n'a pas publié de description pour ce code.

Marché principal en Tchéquie ; disponible dans 17 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08594161958437

Basic UDI-DI

859569630001Q3

Numéro de référence/catalogue

EBV/GP/025

Entité d'attribution

GS1

Catégorie de risque

IVDR Classe C

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The intended purpose of the device is related to the medical context and clinical conditions under which the device may be used. EBV is implicated in a number of diseases, including infectious mononucleosis, Burkitt's lymphoma, Hodgkin's lymphoma, stomach cancer, nasopharyngeal carcinoma, multiple sclerosis and lymphomatoid granulomatosis. Direct evidence of EBV DNA (PCR) is used primarily in the diagnosis of lymphoproliferative diseases in immunodeficient patients, chronic active EBV infections, neurological complications associated with EB viral infection, and in monitoring response to treatment. The kit is an in vitro nucleic acid amplification test intended for quantification and detection of Epstein-Barr Virus (EBV; Human herpesvirus 4) in the following clinical specimens: CSF, plasma, whole blood and BAL. The kit can be used in combination with a manual or automated extraction system. The kit is designed for human in vitro diagnostics and provides both qualitative and quantitative detection. The kit is intended for diagnostics, aid to diagnosis or for monitoring and it is designed for professional use in laboratories with trained staff.

URL des informations complémentaires

https://www.geneproof.com/ifu

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0105040403EBV - NA REAGENTS

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel