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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 ARCHITECT HIV Ag/Ab Combo
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
Supplement NumberS031
Date Received09/24/2013
Decision Date02/06/2014
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement Type135 Day Track for 30 Day Notification
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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