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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 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
Supplement NumberS055
Date Received04/18/2019
Decision Date12/20/2018
Decision 30-Day Notice - No 135-Day Supplement Needed
Product Code
QUM[ Registered Establishments with QUM ]
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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