PlentiPlex

Primary DI

D-5713915PP002TFN8

Basic UDI-DI Code

B-5713915PP002TFN8

Reference

7013; 7014; 7015

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PentaBase A/S

PlentiPlex™ MSI PB Panel Fragment Analysis is a multiplexed Polymerase Chain Reaction (PCR) and fragment analysis assay intended for the qualitative detection of MicroSatellite Stability (MSS)/Instability (MSI) in human DNA from solid biopsies such as Formalin-Fixed Paraffin-Embedded (FFPE) tissue. The assay is used with general PCR systems followed by use with a fragment analysis system such as Applied Biosystems™ 3730/3730xl DNA Analyzer. Samples can be prepared using automated platforms or in manual workflows. MSI is a prognostic marker and a predictive factor of response to therapies. PlentiPlex™ MSI PB Panel Fragment Analysis is an in vitro diagnostic medical device intended as an aid in the selection of treatment options for diseases like cancers. The assay is intended for use by healthcare professionals or qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorization.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).