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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received05/03/2005
Decision Date05/18/2006
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S001 S005 S006 S007 S008 S010 S011 S013 S015 
S018 S021 S023 S026 S027 S029 S031 S033 S034 
S036 S037 S039 S040 S042 
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