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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.
 
Devicedigene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQIAGEN GAITHERSBURG, INC
19300 Germantown Road
Germantown, MD 20874
PMA NumberP890064
Supplement NumberS037
Date Received01/26/2018
Decision Date02/21/2018
Product Code MAQ 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modify the in-process QC methods as described and alter the component specifications for the specified reagent.
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