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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 Viper LT System
Classification Namekit, dna detection, human papillomavirus
Generic Namekit, dna detection, human papillomavirus
7 loveton circle
sparks, MD 21152
PMA NumberP160037
Supplement NumberS001
Date Received04/27/2018
Decision Date03/26/2019
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to plastic resin used for reagent storage containers.