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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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PMA Number P120007 Center Devices Decision Date To 10/26/2016
 
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Aptima HPV 16 18/45 Genotype Assay. GEN-PROBE INCORPORATED P120007 S010 05/04/2017
Aptima HPV 16 18/45 Genotype Assay GEN-PROBE INCORPORATED P120007 S011 02/23/2018
Aptima HPV 16 18/45 Genotype Assay GEN-PROBE INCORPORATED P120007 S012 11/03/2017
Aptima HPV 16 18/45 Genotype Assay GEN-PROBE INCORPORATED P120007 S013 01/18/2018
Aptima HPV 16 18/45 Genotype Assay GEN-PROBE INCORPORATED P120007 S014 03/08/2018
Aptima HPV 16 18/45 Genotype Assay GEN-PROBE INCORPORATED P120007 S015 04/13/2018
Aptima HPV 16 18/45 Genotype Assay GEN-PROBE INCORPORATED P120007 S016 09/13/2018
Aptima HPV 16 18/45 Genotype Assay GEN-PROBE INCORPORATED P120007 S017 09/28/2018
Aptima HPV 16 18/45 Genotype Assay GEN-PROBE INCORPORATED P120007 S018 02/28/2019
Aptima HPV 16 18/45 Genotype Assay GEN-PROBE INCORPORATED P120007 S019 04/22/2019
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