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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 SYSTEM SOFTWARE
Generic Namekit, dna detection, human papillomavirus
ApplicantQIAGEN GAITHERSBURG, INC
19300 germantown road
germantown, MD 20874
PMA NumberP890064
Supplement NumberS031
Date Received09/23/2014
Decision Date10/09/2014
Product Code MAQ 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE UPGRADE OF THE HC2 SOFTWARE SUITE TO VERSION 4.3.
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