TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Primary DI

06959094210557

Basic UDI-DI Code

B-06959094210557

Reference

8.06.0020

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Amoy Diagnostics Co., LTD.

The AmoyDx ® HANDLE Classic NGS Panel is a next-generation sequencing (NGS) based in vitro diagnostic assay intended for qualitative detection of single nucleotide variants (SNVs), insertions and deletions (InDels), gene fusions, copy number amplifications (CNAs) and microsatellite instability (MSI) in 40 key solid tumour genes (see Table S1 and S2), using DNA and RNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens. The assay is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. This assay is not automated and is for laboratory professional use only

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