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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 NumberS010
Date Received05/07/2013
Decision Date05/29/2013
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Qualification of a new supplier for a raw material that is used in the manufacture of the detection kit associated with the inform her-2 dual ish dna probe cocktail. As part of this change in raw material, a change in the cell media used to grow the anti-dnp antibody is also being implemented.
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