GENETIC TESTS - OTHER

Primary DI

06974689626049

Basic UDI-DI Code

B-06974689626049

Reference

Model: EG02-Q16; Specification: 16 Tests Model: EG02-Y16; Specification: 16 Tests

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

TargetingOne Technology (Beijing) Corporation

The EGFR mutations digital PCR detection kit is used for the in vitro qualitative detection of EGFR mutations, including exon 18 G719X mutation, exon 19 deletion mutation (Ex19Del), exon 21 L858R mutation, exon 20 T790M mutation, exon 20 S768I mutation and exon 20 insertion mutation (Ex20Ins), in cell free DNA from plasma samples and formalin-fixed paraffin-embedded (FFPE) tissue DNA of patients with non-small cell lung cancer. This kit is also used to assist in screening patients with non-small cell lung cancer (NSCLC) who can be treated with EGFR tyrosine kinase inhibitors (TKI).

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