Sentosa SQ CRC Panel (4x8)

Primary DI

08885013956085

Basic UDI-DI Code

B-08885013956085

Reference

690012

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SQ CRC Panel (4x8) is a next generation sequencing-based in vitro diagnostic test that simultaneously detects hotspot mutations in 11 genes from formalin-fixed paraffin-embedded (FFPE) samples that have previously demonstrated clinical relevance in the management of patients with colorectal cancer (CRC). This panel is intended to be used on the Sentosa® SX101 with the Sentosa® SX FFPE II gDNA Kit (4x8) in conjunction with the Sentosa® ST401 and Sentosa® SQ301 instruments. The Sentosa® SQ CRC Panel (4x8) is intended to be used as a test to aid the oncologist in clinical decision-making. Results should be used in conjunction with other available laboratory and clinical information and are not intended for use as a stand-alone diagnostic test or disease monitoring.

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