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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 and QS-RGQ MDx Kit
Generic NameCytomegalovirus (cmv) dna quantitative assay
ApplicantQIAGEN, INC.
QAIGEN STRASSE 1
40724
HILDEN 40724
PMA NumberP130027
Supplement NumberS003
Date Received06/29/2017
Decision Date11/15/2017
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 for a change to the enzyme in a component of the device.
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