Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantBecton, Dickinson and Company
7loveton Cir.
Sparks, MD 21152
PMA NumberP160037
Supplement NumberS024
Date Received07/31/2025
Decision Date04/02/2026
Product Code MAQ 
Advisory Committee Microbiology
Clinical TrialsNCT06498661
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expanding settings under which self-collected vaginal (SV) specimens are collected and for adding a workflow for SV specimen processing and testing.
-
-