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.
 
DeviceAlinity m HR HPV Assay
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP230003
Supplement NumberS004
Date Received06/18/2024
Decision Date09/13/2024
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to add AMP Detect insert bar on the Amplification Detection Unit (ADU) ejection bar of the Alinity m System.
-
-