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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.
 
DeviceVIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQiagen, Inc.
1201 Clopper Rd.
Gaithersburg, MD 20878
PMA NumberP880009
Supplement NumberS003
Date Received09/18/1989
Decision Date02/01/1990
Withdrawal Date01/29/2010
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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