TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Primary DI

06959094210854

Basic UDI-DI Code

B-06959094210854

Reference

8.01.23201X012H

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Amoy Diagnostics Co., LTD.

The AmoyDx® ROS1 Gene Fusions Detection Kit is an in vitro nucleic acid amplification test intended for qualitative detection of 14 ROS1 gene fusions in human formalin-fixed paraffin-embedded (FFPE) tumor tissue RNA. The kit is intended to be used to assess ROS1 gene status in NSCLC patients and to aid the clinician in identifying NSCLC patients who may response to ROS1 inhibitor therapy, such as Xalkori®(crizotinib). The kit is to be used by physicians, clinical researchers and trained professionals in a laboratory environment.

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