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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 Abbott RealTime HIV-1 assay
Classification Namehuman immunodeficiency virus (hiv) viral load monitoring test
Generic Namehuman immunodeficiency virus (hiv) viral load monitoring test
Regulation Number866.3958
Applicant
Abbott Molecular
1300 e. touhy avenue
Des Plaines , IL 60018 
  
PMA NumberBP060002
Supplement NumberS042
Date Received08/17/2015
Decision Date11/09/2015
Decision Approved
Product Code
QUM[ Registered Establishments with QUM ]
Advisory Committee Clinical Chemistry
Supplement TypeReal Time Process
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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