Gen Probe Incorporated10210 Genetic Center Drivesan 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

FDA Filings

This page includes the latest FDA filings for Gen Probe Incorporated10210 Genetic Center Drivesan 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. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
GEN-PROBE INCORPORATED10210 Genetic Center Drivesan 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
 Aptima HPV 16 18/45 Genotype Assay2022-02-25

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