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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.
 
DeviceDIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQiagen Gaithersburg, Inc.
19300 Germantown Rd.
Germantown, MD 20874
PMA NumberP890064
Supplement NumberS014
Date Received11/05/2003
Decision Date05/04/2004
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO INCLUDE THE OPTIONAL USE OF AN AUTOMATED, HIGH-THROUGHPUT ROBOTIC PIPETTING AND MICROPLATE HANDLING SYSTEM KNOWN AS THE DIGENE RAPID CAPTURE SYSTEM (RCS).
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