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. |
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Device | BD Onclarity HPV Assay/BD COR System |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE SPARKS, MD 21152 |
PMA Number | P160037 |
Supplement Number | S005 |
Date Received | 01/14/2020 |
Decision Date | 08/24/2021 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for use of the BD Onclarity HPV Assay on the BD COR (PX/GX) instrument system. |
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