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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 VIRATYPE(R) PLUS HPV DNA
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQIAGEN GAITHERSBURG, INC
19300 Germantown Road
Germantown, MD 20874
PMA NumberP890064
Supplement NumberS003
Date Received09/27/1993
Decision Date04/28/1995
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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