• 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.
 
DeviceAptima HPV 16 18/45 Genotype Assay
Generic Namekit, rna detection, human papillomavirus
ApplicantGEN-PROBE INCORPORATED
10210 genetic center drive
san diego, CA 92121
PMA NumberP120007
Supplement NumberS029
Date Received12/14/2021
Decision Date02/25/2022
Product Code OYB 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to support the addition of the optional use of an automated dishwasher (Miele Dishwasher) to wash Panther Trax shuttle shields, sample racks, and storage racks used with the Aptima HPV assays.
-
-