EGFR Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

Primary DI

06972665701063

Basic UDI-DI Code

B-06972665701063

Reference

Lotus NL B.V. Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]

Device Types

Single use Sterilization

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

XIAMEN SPACEGEN CO.,LTD.

The kit is intended for the detection of 29 somatic mutations (Attached List 1) of EGFR gene in FFPE pathological tissue collected from patients with non-small cell lung cancer (NSCLC) or colorectal cancer. The assay is indicated only for use as an aid in the identification of patients who may benefit from the EGFR-TKIs treatment. The results shall not be regarded as the only evidence whether a patient suits individualized therapy; clinically, determinants such as, but not limited to patients’ condition, drug indications, therapeutic response, and other laboratory detection indexes should also be considered before making comprehensive judgments. The multiplex fluorescence Polymerase Chain Reaction (PCR) tech applied in this kit is intended for use on real-time PCR systems.

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