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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
Regulation Number866.3180
ApplicantQiagen, Inc.
Qaigen Strasse 1
40724
Hilden 40724
PMA NumberP130027
Supplement NumberS001
Date Received06/12/2015
Decision Date07/09/2015
Reclassified Date10/23/2024
Product Code PAB 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE SUPPLIER OF THE POSITIVE MATERIALS USED IN THE ARTUS CMV RGQ MDX KIT.
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