510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NXGClass III

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

Unknown
FDA source (opens on fda.gov)

NXG is the FDA product code for Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NXG
Device name
Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NXG.