• 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 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.
Classification Namecytomegalovirus (cmv) dna quantitative assay
Generic Namecytomegalovirus (cmv) dna quantitative assay
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP110037
Date Received10/24/2011
Decision Date07/05/2012
Product Code
PAB[ Registered Establishments with PAB ]
Docket Number 12M-0713
Notice Date 07/11/2012
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cobas ampliprep/cobas taqman cmv test. This device is indicated for: the cobas ampliprep/cobas taqman cmv test is an in vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (cmv) dna in human edta plasma using the cobas ampliprep instrument for automated specimenprocessing and the cobas taqman analyzer or the cobas taqman 48 analyzer for automated amplification and detection. The cobas ampliprep/ cobas taqman cmv test is intended for use as an aid in the management of solid-organ transplant patients who are undergoing anti-cmv therapy. In this population serial dna measurements can be used to assess virological response to antiviral treatment. The results from the cobas ampliprep/cobas taqman cmvtest must be interpreted within the context of all relevant clinical and laboratory findings. The cobas ampliprep/cobas taqman cmv test is not intended for use as a screening test for the presence of cmv dna in blood or blood products.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029