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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 ARCHITECT HIV Ag/Ab Combo Assay
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
Abbott Laboratories
100 abbott park road dept t3m2 bldg ap20
Abbott Park , IL 60064 -3500
  
PMA NumberBP090080
Date Received12/22/2009
Decision Date06/18/2010
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement TypeExpedited PMA
Expedited Review Granted? Yes
Third Party Review Elligble? No
Combination ProductNo
Supplements: S001 S003 S004 S005 S007 S008 S009 S011 S012 
S013 S014 S015 S016 S017 S018 S020 S021 S022 
S023 S026 S027 S030 S031 S032 S033 S034 S035 
S039 S040 S041 S043 S044 S046 S047 S049 S050 
S051 S053 S054 S056 S059 S060 S061 S063 S065 
S067 S068 S069 S070 S071 
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