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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.
 
DeviceCOBAS HPV TEST
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP100020
Supplement NumberS013
Date Received02/25/2015
Decision Date05/01/2015
Product Code MAQ 
Advisory Committee Microbiology
Clinical TrialsNCT00709891
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR CHANGES TO THE MAGNETIC GLASS PARTICLE (MGP) REAGENT BOTTLES AND CLOSURES.
Post-Approval StudyShow Report Schedule and Study Progress
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