TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Primary DI

06959094210588

Basic UDI-DI Code

B-06959094210588

Reference

8.06.0002

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Amoy Diagnostics Co., LTD.

The AmoyDx® Essential 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, and copy number variations (CNVs) in 10 oncogenic driver genes (see Table 1), using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens, or circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood specimens. The detection of CNVs is available for tissue-derived DNA only. 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 non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). 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).