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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 Ag/Ab Combo (CHIV) Assay
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
Siemens Healthcare Diagnostics, Inc.
511 benedict ave
Tarrytown , NY 10591 
  
PMA NumberBP140103
Supplement NumberS008
Date Received10/02/2017
Decision Date10/04/2018
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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