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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 NumberS004
Date Received07/28/2017
Decision Date03/13/2018
Reclassified Date10/23/2024
Product Code PAB 
Advisory Committee Microbiology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for relocation of a manufacturing process.
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