A58428

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 2 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08595696304355

Basic UDI-DI

859569630009QK

Numéro de référence/catalogue

A58428

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. CMV is implicated in infectious mononucleosis. CMV implicated diseases can present in many ways including fever, pneumonia, pneumonitis, colitis, hepatitis, myocarditis, esophagitis, gastrointestinal ulcerations, diarrhoea, retinitis, visual impairment, blindness, polyradiculopathy, transverse myelitis, encephalopathy, encephalitis, seizures, and coma. Congenital CMV infections can result in non-specific symptoms and include rhinitis, pharyngitis, myalgia, arthralgia, headache and fatigue. The GeneProof Cytomegalovirus (CMV) PCR Kit is an in vitro nucleic acid amplification test intended for quantification and detection of Cytomegalovirus (CMV; Human beta herpesvirus 5) by real-time polymerase chain reaction (PCR) method. The clinical specimens used for detection are CSF, plasma, serum, urine, whole blood. The GeneProof Cytomegalovirus (CMV) PCR 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, an aid to diagnosis and for monitoring, and it is designed for professional use in laboratories with trained staff.

URL des informations complémentaires

https://thermofisher.com/geneproofIFU

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0105040205CMV - NA REAGENTS

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