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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
Trade NameCOBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
Classification Namecytomegalovirus (cmv) dna quantitative assay
ApplicantROCHE MOLECULAR SYSTEMS, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 specimen processing 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 cmv test 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
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 
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