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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.
 
DeviceHCS HPV, HCII HPV
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQIAGEN GAITHERSBURG, INC
19300 Germantown Road
Germantown, MD 20874
PMA NumberP890064
Supplement NumberS008
Date Received08/25/2000
Decision Date09/12/2000
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT DIGENE CORPORATION, GAITHERSBURG, MD, 20878.
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