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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 Alinity m HIV-1 AMP 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, Inc.
1300 east touhy ave
Des Plaines , IL 60018 
  
PMA NumberBP200455
Supplement NumberS007
Date Received12/27/2021
Decision Date07/08/2022
Decision Approved
Product Code
QUM[ Registered Establishments with QUM ]
Advisory Committee Clinical Chemistry
Supplement TypePanel Track
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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