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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
Generic Namein vitro diagnostic test kit for her2 gene amplification in formalin-fixed, paraffin-embedded (ffpe) tissue sections cho
PMA NumberP050040
Supplement NumberS002
Date Received03/03/2011
Decision Date04/29/2011
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the product insert: 1) manufacturing address change; 2) copyright change from invitrogen corporation to life technologies. Invitrogen will remain the brand name and therefore is still included on the product insert and labeling; and an addition of literature references to the bibliography.