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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCOBAS CMV
Generic Namecytomegalovirus (cmv) dna quantitative assay
ApplicantROCHE MOLECULAR SYSTEMS, INC.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP160041
Date Received09/21/2016
Decision Date06/01/2017
Product Code PAB 
Docket Number 17M-3430
Notice Date 06/07/2017
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the cobas CMV test - This device is indicated for:cobas® CMV is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus (CMV) DNA in human EDTA plasma. cobas® CMV is intended for use as an aid in the management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results from cobas® CMV must be interpreted within the context of all relevant clinical and laboratory findings. cobas® CMV is not intended for use as a screening test for blood or blood products.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S030 S031 S032 S033 S034 
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