Idylla™ CDx MSI Test

Nom de l'organisation

Biocartis NV

SRN

BE-MF-000003661

Statut du fabricant

Actif

Marché principal en Belgique ; disponible dans 32 pays au total.

Dénomination commerciale

Idylla™ CDx MSI Test

Code d'UDI-DI

15415219001328

Basic UDI-DI

5415219A0220BV

Numéro de référence/catalogue

A0220/6

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

6

Description complémentaire du produit

The Idylla™ CDx MSI Test is an in vitro diagnostic test intended for the qualitative detection of a novel panel of seven (7) monomorphic biomarkers for identification of microsatellite instability (MSI) in colorectal cancer tissue. The Idylla™ CDx MSI Test uses formalin-fixed, paraffin embedded (FFPE) tissue sections from human colorectal cancer (CRC), from which nucleic acids are liberated, then analyzed by PCR amplification and high-resolution melting detection. The Idylla™ CDx MSI Test automates the entire process from FFPE specimen processing to reporting of MSI status as either Microsatellite Stable (MSS) or Microsatellite Instability-High (MSI-H). The Idylla™ CDx MSI Test is intended for identification of adult patients with MSI-H metastatic CRC, for whom treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab) as a combination therapy is indicated with approved therapeutic product labeling.

URL des informations complémentaires

https://www.biocartis.com/ifu

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W01060214COLORECTAL CANCER (MSI-H / DMMR)

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