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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.
 
Trade NameSPOT-LIGHT HER2 CISH KIT
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
ApplicantLIFE TECHNOLOGIES, INC.
PMA NumberP050040
Supplement NumberS001
Date Received02/03/2011
Decision Date07/12/2011
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located in frederick, maryland.
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