MicroSight

Primary DI

D-5713915MS001SZNU

Basic UDI-DI Code

B-5713915MS001SZNU

Reference

7200;7201;7205;7210

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PentaBase A/S

MicroSight® MSI 1-step HRM analysis is based on Real-Time Polymerase Chain Reaction (RT-PCR) followed by high-resolution melt (HRM) study on a BaseTyper™ 48.4 Quiet HRM Real-Time PCR System. The assay is intended for the qualitative evaluation of microsatellite stability (MSS)/instability (MSI), in human DNA from solid biopsies such as Formalin-Fixed Paraffin-Embedded (FFPE) tissue. MSI is known as a prognostic marker and a predictive factor of response to certain therapies like check point inhibitors and 5-fluorouracil. MicroSight® MSI 1-step HRM analysis is an in vitro diagnostic medical device intended as an aid to correct treatment selection. The assay is intended for use by healthcare professionals or qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR, HRM measurements 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).