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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 Aptima HIV-1 Quant Dx assay
Classification Namehuman immunodeficiency virus (hiv) viral load monitoring test
Generic Namehuman immunodeficiency virus (hiv) viral load monitoring test
Regulation Number866.3958
Applicant
Hologic, Inc.
10210 genetic center drive
San Diego , CA 92121 
  
PMA NumberBP150318
Date Received09/15/2015
Decision Date12/22/2016
Decision Approved
Product Code
QUM[ Registered Establishments with QUM ]
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S002 S004 S005 S006 S007 S008 S009 S012 S013 
S014 S015 S016 S018 S020 S021 S026 S027 S028 
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