Gen Probe

FDA Filings

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

FDA Filings

Device Company	Device	Date
PMA P020011S016 GEN-PROBE	Aptima HCV RNA Qualitative Assay	2020-07-21
PMA P020011S015 GEN-PROBE	Aptima HCV RNA Qualitative Assay	2020-02-14
PMA P020011S014 GEN-PROBE	Aptima HCV RNA Qualitative Assay	2019-06-21
PMA P020011S013 GEN-PROBE	APTIMA HCV RNA Qualitative Assay	2019-04-26
PMA P020011S012 GEN-PROBE	Aptima HCV RNA Qualitative Assay	2019-03-21
PMA P020011S011 GEN-PROBE	Aptima HCV RNA Qualitative Assay	2018-10-31
PMA P020011S010 GEN-PROBE	Aptima HCV RNA Qualitative Assay	2017-11-03
PMA P020011S009 GEN-PROBE	APTIMA HCV RNA QUALITATIVE ASSAY	2016-09-19
PMA P020011S008 GEN-PROBE	APTIMA HCV RNA QUALITATIVE ASSAY	2015-05-08
PMA P020011S007 GEN-PROBE	VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY	2013-04-08
PMA P020011S006 GEN-PROBE	APTIMA HCV RNA QUALITATIVE ASSAY	2013-01-09
PMN BK120063 Gen-Probe	Qualitative Test For HLA, Non-diagnostic	2012-11-21
PMA P020011S005 GEN-PROBE	VERSANT HCV RNA QUALITATIVE ASSAY	2012-06-25
PMN BK110002 Gen-Probe	Qualitative Test For HLA, Non-diagnostic	2011-12-02
PMA P020011S004 GEN-PROBE	VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY	2010-09-17
PMA P020011S002 GEN-PROBE	VERSANT & APTIMA HCV RNA QUALITATIVE ASSAY	2010-09-17
PMA P020011S003 GEN-PROBE	VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY	2010-04-23
PMA P020011S001 GEN-PROBE	VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY	2009-05-22
PMN BK060021 Gen-Probe	Automated Bloodborne Pathogen Test Equipment	2007-02-20
PMN BK050007 Gen-Probe	Automated Bloodborne Pathogen Test Equipment	2005-04-29
PMA P020011 GEN-PROBE	VERSANT HCV RNA QUALITATIVE ASSAY	2002-11-07
PMN BK000051 Gen-Probe	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2002-02-08

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• 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