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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceVIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQIAGEN GAITHERSBURG, INC
19300 Germantown Road
Germantown, MD 20874
PMA NumberP890064
Date Received11/17/1989
Decision Date03/11/1991
Product Code MAQ 
Docket Number 91M-0108
Notice Date 04/10/1991
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S012 S013 
S014 S015 S017 S018 S020 S021 S022 S023 S024 S025 S026 S027 
S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 
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