847-0207610096

Dénomination commerciale

non renseigné

04262386730117

B-04262386730117

Numéro de référence/catalogue

847-0207610096

GS1

IVDD — Annexe II Liste A

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 RoboGene HCV RNA Quantification Kit 3.0 is intended for real-time PCR quantification of Hepatitis C Virus (HCV) RNA in human EDTA- or citrate plasma and serum samples. For specimen purification the manual method (INSTANT Virus RNA/DNA Kit) as well as the automated method (INSTANT Virus RNA/DNA Kit - FX) is validated. For amplification and detection the RoboGene HCV RNA Quantification Kit 3.0 is validated on the following real-time PCR devices: qTOWER 2 & 3; CFX96; LightCycler® 480; 7500 Fast, Rotor-Gene® 3000/6000/Q; RealLine Cycler 48-4/48-5/96-4/96-5 and QuantStudio 5. The assay is purposed for the clinical management of patients with chronic HCV in conjunction with clinical presentation and other laboratory markers for HCV infection. This test is intended to assess viral response to antiviral treatment as measured by changes in plasma and serum HCV RNA levels. Furthermore, in a course of antiviral therapy the probability of a sustained viral response can be judged. The RoboGene HCV RNA Quantification Kit 3.0 is not intended for use as a screening test for the detection of HCV RNA in blood or blood products or as a diagnostic test to confirm the presence of HCV infection.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0105020307HEPATITIS C VIRUS - NA REAGENTS

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

• CW010

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