Premarket Approval (PMA)

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.

• Device: BD Onclarity HPV Assay, BD Viper LT System
• Generic Name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
• Applicant: Becton, Dickinson and Company; 7loveton Cir.; Sparks, MD 21152
• PMA Number: P160037
• Supplement Number: S001
• Date Received: 04/27/2018
• Decision Date: 03/26/2019
• Product Code: MAQ
• Advisory Committee: Microbiology
• Supplement Type: 135 Review Track For 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a change to plastic resin used for reagent storage containers.