TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Primary DI

06975977070209

Basic UDI-DI Code

B-06975977070209

Reference

600020

Device Types

Single use Sterilization

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Gold Probe Diagnostic Biotechnology Inc. MF

IDH1/IDH2 Gene Mutation Detection Kit （Real-time PCR Assays） is used to qualitatively detect hot spot mutations of IDH1 and IDH2 gene, including R132 in IDH1 and R172 in IDH2, in tumor tissue samples of neutral formaldehyde-fixed paraffin specimens in tumor patients, and provide a reference for clinicians to diagnose and treat patients. The kit is for in vitro diagnostic use, its use requires the operation of a trained professionals in a laboratory environment.

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