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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 NumberS034
Date Received03/28/2022
Decision Date06/02/2023
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 addition of manual post-cytology (cytology by ThinPrep Genesis Processor) aliquot, pre-cytology aliquot and post-cytology (cytology by ThinPrep Genesis Processor) aliquot removed by the ThinPrep Genesis Processor as acceptable samples for the Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay.
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