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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device cobas HIV-1
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 NumberBP150262
Date Received05/11/2015
Decision Date12/18/2015
Decision Approved
Product Code
QUM[ Registered Establishments with QUM ]
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S002 S003 S004 S005 S006 S008 S009 S010 S012 
S013 S014 S015 S017 S018 S019 S020 S021 S022 
S023 S024 S025 S026 S027 S028 S030 S031 S032 
S033 S034 S035 S036 S037 S038 S039 S040 S041 
S043 S044 S045 S046 S047 S048 S049 S050 S051 
S053 S055 S056 
-
-