SensiScreen

Primary DI

D-5713915SS013VARA

Basic UDI-DI Code

B-5713915SS013VARA

Reference

1154; 1846

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PentaBase A/S

SensiScreen® FFPE KIT qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the semi-quantitative detection of specific somatic KIT proto-oncogene (KIT) gene mutations in human DNA purified from solid biopsies such as Formalin-Fixed Paraffin-Embedded (FFPE) tissue. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. SensiScreen® FFPE KIT qPCR Assay is an in vitro diagnostic medical device intended to detect, identify, and quantify the KIT somatic mutational status as an aid in selecting the proper treatment of cancer. SensiScreen® FFPE KIT qPCR Assay is intended for use by healthcare professionals or qualified laboratory personnel 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).