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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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New Search Biologics Premarket Approvals (PMAs) Back to Search Results
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 Abbott RealTime HIV-1 Amplification Reagent Kit; Abbott RealTime HIV-1 Calibrator Kit; Abbott RealTime HIV-1 Control Kit
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
Date Received12/30/2005
Decision Date05/11/2007
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: S006 S007 S008 S009 S010 S013 S014 S016 S018 
S021 S022 S025 S026 S027 S028 S029 S031 S032 
S034 S036 S037 S038 S042 S043 S044 S045 S046 
S048 S049 S051 S052 S054 S055 S056 S059 S061 
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