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.
Approval for a post approval study labeling update.
|Device||BD Onclarity HPV Assay|
|Classification Name||Kit, Dna Detection, Human Papillomavirus|
|Generic Name||Kit, Dna Detection, Human Papillomavirus|
|Applicant||BECTON, DICKINSON AND COMPANY|
|Supplement Type||Normal 180 Day Track No User Fee|
|Supplement Reason||Labeling Change - Pas|
|Applicant Address||BECTON, DICKINSON AND COMPANY 7 Loveton Circle sparks, MD 21152|
|Supplement Number||Date||Supplement Type|
|S003||2019-08-21||Normal 180 Day Track No User Fee|
|S001||2018-04-27||135 Review Track For 30-day Notice|