Sentosa SQ NSCLC Panel (4x8)

Primary DI

08885013956061

Basic UDI-DI Code

B-08885013956061

Reference

690010

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa SQ NSCLC 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 non-small cell lung cancer (NSCLC). 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 NSCLC 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).