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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDAKO TOP2A FISH PHARMDX KIT
Classification Namefluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
ApplicantDAKO DENMARK A/S
PMA NumberP050045
Date Received11/30/2005
Decision Date01/11/2008
Product Code
NXG[ Registered Establishments with NXG ]
Docket Number 08M-0182
Notice Date 03/20/2008
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the top2a fish pharmdx kit. The device is indicated for: top2a fish pharmdx kit is designed to detect amplifications and deletions (copy number changes) of the top2a gene using fluorescence in situ hybridization (fish) technique on formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Deletions and amplifications of the top2a gene serve as a marker for poor prognosis in high-risk breast cancer patients. Results from the top2a fish pharmdx kit are intended for use as an adjunct to existing clinical and pathological information.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 
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