Product code NXG

Device name
Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
Medical specialty
Unknown
Device class
3
Review panel
PA
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset