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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 HER2 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 NumberS006
Date Received03/05/2013
Decision Date04/02/2013
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add an alternate qualified supplier for subassemblies used in the production of the benchmark ultra and benchmark xt instruments, critical components used in the manufacture of the subject reagents.
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