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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
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantBecton, Dickinson and Company
7loveton Cir.
Sparks, MD 21152
PMA NumberP160037
Supplement NumberS022
Date Received02/26/2025
Decision Date08/25/2025
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Becton, Dickinson and Company, at 7 Loveton Circle, Sparks, MD, 21152, USA, for the manufacturing of the BD COR PX instrument.
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