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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceARTUS CMV RGQ MDX KIT
Generic NameCytomegalovirus (cmv) dna quantitative assay
ApplicantQIAGEN, INC.
QAIGEN STRASSE 1
40724
HILDEN 40724
PMA NumberP130027
Supplement NumberS002
Date Received11/14/2016
Decision Date06/02/2017
Product Code PAB 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to expand the use of the artus CMV RGQ MDx assay system to include the QIAsymphony RGQ MDx system. The new assay system includes the QIAsymphony SP instrument and QIAsymphony DSP Virus/Pathogen Kit for automated sample preparation, automated assay setup on the QIAsymphony AS, artus CMV QS­ RGQ MDx Kit, and Rotor-Gene Q MDx instrument with Rotor-Gene AssayManager v1.0 software.
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