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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.
 
DeviceHYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQIAGEN GAITHERSBURG, INC
19300 Germantown Road
Germantown, MD 20874
PMA NumberP890064
Supplement NumberS005
Date Received11/01/1996
Decision Date08/15/1997
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for use of a cervical broom specimen collected and transported in the Cytyc Corporation PreservCyt(R) Solution for testing in the Digene Corporation Hybrid Capture(TM) System HPV DNA Assay.
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