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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 NameINFORM HER-2 DUAL ISH DNA PROBE COCKTAIL
Classification Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
ApplicantVENTANA MEDICAL SYSTEMS, INC.
PMA NumberP100027
Supplement NumberS004
Date Received09/26/2012
Decision Date11/21/2012
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the change of the two liter (2l) bottles for each of the aqueous-based reagents from fluorinated to non-fluorinated bottles.
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