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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 Aptima HIV-1 Quant 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
Supplement NumberS008
Date Received11/29/2018
Decision Date12/14/2018
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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