NXG

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

Product code

NXG

Device name

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification definition

Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen.

Definition text from the FDA device classification database (U.S. federal government work, public domain).