Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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-RGO MDx Kit
Generic NameCytomegalovirus (cmv) dna quantitative assay
Regulation Number866.3180
ApplicantQiagen, Inc.
Qaigen Strasse 1
40724
Hilden 40724
PMA NumberP130027
Supplement NumberS006
Date Received08/30/2018
Decision Date09/26/2018
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  
Modify the bulk manufacturing process and QC testing for an assay control reagent.
-
-