Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Biologics Premarket Approvals (PMAs) Back to Search Results
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 Dx 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 NumberS016
Date Received12/23/2019
Decision Date03/18/2020
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
-
-