TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Primary DI

06959094212483

Basic UDI-DI Code

B-06959094212483

Reference

8.01.20213X012E

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Amoy Diagnostics Co., LTD.

The Super-ARMS ® EGFR Mutation Detection Kit is a real-time PCR assay for qualitative detection of 42 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 ctDNA extracted from plasma sample. The kit is intended to be used to assess EGFR mutation status in NSCLC patients and aid in identifying patients who may respond to 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).