|Trade Name||TOP2A FISH PHARMADX KIT|
|Classification Name||fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion|
|Applicant||DAKO DENMARK A/S|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the manufacturing process of pma oligomers in the device.