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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.
 
DeviceBD Onclarity HPV Assay/BD COR System
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantBecton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152
PMA NumberP160037
Supplement NumberS005
Date Received01/14/2020
Decision Date08/24/2021
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
RecallsCDRH Recalls
Approval Order Statement  
Approval for use of the BD Onclarity HPV Assay on the BD COR (PX/GX) instrument system.
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