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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 Assay
Generic Namekit, rna detection, human papillomavirus
ApplicantGEN-PROBE INCORPORATED
10210 genetic center drive
san diego, CA 92121
PMA NumberP100042
Supplement NumberS027
Date Received11/01/2019
Decision Date04/27/2020
Product Code OYB 
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the use of ThinPrep 5000 post-processed samples on the Aptima HPV Assay.
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