Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
NXG · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NXG
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
PA
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.