MicroSight® MSI 1-Step HRM Analysis

Nom de l'organisation

PentaBase A/S

SRN

DK-MF-000023157

Statut du fabricant

Actif

3 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW266

  EUDAMED n'a pas publié de description pour ce code.
• CW009

  The buffers, primer/probe, and tubes are not to be reused
• CW036

  MicroSight® MSI 1-step HRM Analysis can only be run on a BaseTyper™ 48.4, a Gentier or a MyGo PCR RealTime PCR System

Marché principal en Danemark ; disponible dans 2 pays au total.

Dénomination commerciale

MicroSight® MSI 1-Step HRM Analysis

Code d'UDI-DI

05713915000441

Basic UDI-DI

5713915MS001SZ

Numéro de référence/catalogue

7201

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

16

Description complémentaire du produit

MicroSight® MSI 1-step HRM Analysis is an in vitro diagnostic medical device designed to qualitatively detect microsatellite stability (MSS) or instability (MSI) through the analysis of mutations in five mononucleotide loci (BAT25, BAT26, NR22, NR24, and MONO27) using a semi-automated real-time polymerase chain reaction (qPCR) followed by high-resolution melting (HRM) analysis. MicroSight® MSI 1-step HRM Analysis is specifically intended for use with human DNA extracted from biopsies from solid tumors, including formalin-fixed paraffin-embedded (FFPE) tissue. The MicroSight® MSI 1-step HRM Analysis is intended to aid in diagnosing deficiencies in the mismatch repair (MMR) system through the analysis of microsatellite stability and instability in patients diagnosed with colorectal or endometrial cancer. MicroSight® MSI 1-step HRM Analysis is intended for use with patients already diagnosed with cancer who may benefit from additional genetic testing, to diagnose Lynch syndrome. Test results obtained using the product must be interpreted by healthcare professionals with other clinical findings, family history and laboratory data. It is not intended as a companion diagnostic device. The assay is intended for use by healthcare professionals, or qualified laboratory personnel, proficient in handling biological samples and specifically instructed and trained in the techniques of real-time PCR and HRM measurements.

URL des informations complémentaires

https://5ba.se/ms001

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