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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 NumberS028
Date Received05/22/2026
Decision Date08/14/2026
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the extension of self-collected vaginal specimen transport and storage conditions for the BD Onclarity HPV Assay.
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