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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 and artus CMV QS_RGQ MDx Kit
Generic NameCytomegalovirus (cmv) dna quantitative assay
Regulation Number866.3180
ApplicantQiagen, Inc.
Qaigen Strasse 1
40724
Hilden 40724
PMA NumberP130027
Supplement NumberS005
Date Received03/08/2018
Decision Date04/06/2018
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 the supplier and the polymer used for a kit consumable.
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