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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 Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk
Generic Namekit, dna detection, human papillomavirus
19300 germantown road
germantown, MD 20874
PMA NumberP890064
Supplement NumberS033
Date Received02/19/2016
Decision Date04/15/2016
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 a new version of the HC2 Software Suite (version 4.4) and a new hardware model of the PC used with this software.