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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: S021 S025 S026  S029 S022 S023 S024 S008 S018 S020 S027 
S006 S033 S032 S031 S015 S017 S012 S007 S009 S013 S014 S030 
S001 S002 S003 S005 S004 S034 S035 S036 S037 S038 S039 S040 
S041 
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