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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.
DeviceOnclarity HPV Assay
Generic Namekit, dna detection, human papillomavirus
7 loveton circle
sparks, MD 21152
PMA NumberP160037
Supplement NumberS002
Date Received02/26/2019
Decision Date05/13/2019
Product Code MAQ 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of a modified SurePath vial for collection of specimens to be tested with the Onclarity HPV Assay, and the automated transfer of pre- and post- cytology aliquots using the BD Totalys Multiprocessor for testing with the BD Onclarity Assay.