TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Primary DI

06959094206024

Basic UDI-DI Code

B-06959094206024

Reference

8.01.0134

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Amoy Diagnostics Co., LTD.

The AmoyDx® EGFR 29 Mutations Detection Kit is a real-time PCR assay for qualitative detection of 29 somatic mutations in exons 18, 19, 20 and 21 of EGFR gene in human genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue, or circulating DNA extracted from plasma/serum. The kit is intended to assess EGFR mutation status in NSCLC patients and aid in identifying patients who may respond to the treatment with an EGFR-TKI. The kit is for in vitro diagnostic use, and intended to be used by trained professionals in a laboratory environment.

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