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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 HPB 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 NumberS038
Date Received02/16/2018
Decision Date03/14/2018
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  
Change in-process QC testing and sampling of a raw material used to manufacture kit subcomponents.
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