• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search 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.
 
Trade NameCOBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST
Classification Namehepatitis viral b dna detection
Generic Namecobas taqman hbv test for use with the high pure system
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP050028
Supplement NumberS035
Date Received08/14/2013
Decision Date09/12/2013
Product Code
MKT[ Registered Establishments with MKT ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the oligonucleotide manufacturing process for the devices.
-
-