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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 HPV DNA TEST
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQiagen Gaithersburg, Inc.
19300 Germantown Rd.
Germantown, MD 20874
PMA NumberP890064
Supplement NumberS021
Date Received02/03/2010
Decision Date03/31/2010
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A TRADE NAME CHANGE FOR THE HYBRID CAPTURE 2 (HC2) HIGH-RISKHPV DNA TEST AND HYBRID CAPTURE 2 (HC2) HPV DNA TEST. THE DEVICES, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST ANDDIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND ARE INDICATED FOR THE QUALITATIVE DETECTIONOF SPECIFIED TYPES OF HUMAN PAPILLOMAVIRUS (HPV) DNA IN CERVICAL SPECIMENS.
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