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 COBAS® AmpliPrep/ COBAS® TaqMan® HIV-1 Test; COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v 2.
Classification Namehuman immunodeficiency virus (hiv) viral load monitoring test
Generic Namehuman immunodeficiency virus (hiv) viral load monitoring test
Regulation Number866.3958
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
Pleasanton, , CA 94588 -2722
  
PMA NumberBP050069
Supplement NumberS045
Date Received12/12/2011
Decision Date10/26/2012
Decision Approved
Product Code
QUM[ Registered Establishments with QUM ]
Advisory Committee Clinical Chemistry
Supplement Type135 Day Track for 30 Day Notification
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
-
-