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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.
 
DeviceARTUS CMV RGQ MDX KIT
Generic Namecytomegalovirus (cmv) dna quantitative assay
ApplicantQIAGEN, INC.
qaigen strasse 1
40724
hilden 40724
PMA NumberP130027
Date Received12/05/2013
Decision Date06/02/2014
Product Code PAB 
Docket Number 14M-0866
Notice Date 06/30/2014
Advisory Committee Microbiology
Clinical TrialsNCT01034709
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ARTUS CMV RGQ MDX KIT. THIS DEVICE IS INDICATED FOR: THE ARTUS CMV RGQ MDX KIT IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HUMAN CYTOMEGALOVIRUS (CMV) DNA IN HUMAN EDTA PLASMA. THE ARTUS CMV RGQ MDX KIT IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF SOLID ORGAN TRANSPLANT PATIENTS WHO ARE UNDERGOING ANTI-CMV THERAPY. THE TEST MEASURES CMV DNA LEVELS IN EDTA PLASMA AND CAN BE USED TO ASSESS CMV VIRAL LOAD RESPONSE TO ANTIVIRAL DRUG THERAPY. THE RESULTS FROM THE ARTUS CMV RGQ MDX KIT MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. THE ARTUS CMV RGQ MDX KIT IS CONFIGURED FOR USE WITH THE EZ1 DSP VIRUS SYSTEM (EZ1 DSP VIRUS KIT AND EZ1 ADVANCED INSTRUMENTS) FOR DNA EXTRACTION AND THE ROTOR-GENE Q MDX INSTRUMENT FOR CMV DNA AMPLIFICATION AND QUANTITATION. THE ARTUS CMV RGQ MDX KIT 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 
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