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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.
 
Device ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
Siemens Healthcare Diagnostics
511 benedict ave
Tarrytown , NY 10591 
  
PMA NumberBP050030
Supplement NumberS005
Date Received12/15/2008
Decision Date05/04/2009
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement TypeReal Time Process
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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