Gen Probe Inc

FDA Filings

This page includes the latest FDA filings for Gen Probe Inc. 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 P100042S033 GEN-PROBE INCORPORATED	Aptima HPV Assay	2022-01-28
PMA P120007S028 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2020-07-21
PMA P100042S031 GEN-PROBE INCORPORATED	Aptima HPV Assay	2020-07-21
PMA P100033S012 GEN-PROBE INCORPORATED	Progensa PCA3 Assay	2020-07-21
PMA P120007S027 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2020-06-11
PMA P100042S030 GEN-PROBE INCORPORATED	Aptima HPV Assay	2020-06-11
PMA P100033S011 GEN-PROBE INCORPORATED	Progensa PCA3 Assay	2020-06-08
PMA P100042S029 GEN-PROBE INCORPORATED	Aptima HPV Assay	2020-02-10
PMA P120007S026 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2020-01-21
PMA P100042S028 GEN-PROBE INCORPORATED	Aptima HPV Assay	2020-01-21
PMA P120007S024 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2019-09-16
PMA P100042S026 GEN-PROBE INCORPORATED	Aptima HPV Assay	2019-09-16
PMA P120007S023 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2019-08-27
PMA P100042S025 GEN-PROBE INCORPORATED	Aptima HPV Assay	2019-08-27
PMA P120007S020 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 Genotype Assay	2019-04-28
PMA P100042S022 GEN-PROBE INCORPORATED	APTIMA HPV Assay	2019-04-28
PMA P120007S021 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 Genotype Assay	2019-04-26
PMA P100042S023 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2019-04-26
PMA P120007S019 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2019-04-22
PMA P100042S021 GEN-PROBE INCORPORATED	Aptima HPV Assay	2019-03-21
PMA P100033S010 GEN-PROBE INCORPORATED	Progensa PCA3 Assay	2019-03-15
PMA P120007S018 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2019-02-28
PMA P100042S020 GEN-PROBE INCORPORATED	Aptima HPV Assay	2019-02-28
PMA P100033S009 GEN-PROBE INCORPORATED	Progensa PCA3 Assay	2018-10-18
PMA P120007S017 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2018-09-28
PMA P100042S019 GEN-PROBE INCORPORATED	Aptima HPV Assay	2018-09-28
PMA P120007S016 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2018-09-13
PMA P100042S018 GEN-PROBE INCORPORATED	Aptima HPV Assay	2018-09-13
PMA P120007S015 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2018-04-13
PMA P100042S017 GEN-PROBE INCORPORATED	Aptima HPV Assay	2018-04-13
PMA P120007S014 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2018-03-08
PMA P100042S016 GEN-PROBE INCORPORATED	Aptima HPV Assay	2018-03-08
PMA P100033S008 GEN-PROBE INCORPORATED	Progensa PCA3 Assay	2018-03-07
PMA P100042S013 GEN-PROBE INCORPORATED	Aptima HPV Assay	2018-02-28
PMA P120007S011 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2018-02-23
PMA P120007S013 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2018-01-18
PMA P100042S015 GEN-PROBE INCORPORATED	Aptima HPV Assay	2018-01-18
PMA P120007S012 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay	2017-11-03
PMA P100042S014 GEN-PROBE INCORPORATED	Aptima HPV Assay	2017-11-03
PMA P100033S007 GEN-PROBE INCORPORATED	Progensa PCA3 Assay	2017-11-03
PMA P120007S010 GEN-PROBE INCORPORATED	Aptima HPV 16 18/45 Genotype Assay.	2017-05-04
PMA P100042S012 GEN-PROBE INCORPORATED	Aptima HPV Assay	2017-05-04
PMA P120007S006 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 GENOTYPE ASSAY	2016-09-19
PMA P100042S008 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2016-09-19
PMA P120007S009 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 GENOTYPE ASSAY	2016-09-13
PMA P100042S011 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2016-09-13
PMA P100042S010 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2016-05-20
PMA P120007S008 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 GENOTYPE ASSAY	2016-03-28
PMA P100042S007 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2015-11-24
PMA P100033S004 GEN-PROBE INCORPORATED	PROGENSA PCA3 ASSAY	2015-11-12
PMA P120007S007 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 GENOTYPE ASSAY	2015-11-09
PMA P100042S009 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2015-11-09
PMA P100033S006 GEN-PROBE INCORPORATED	PROGENSA PCA3 ASSAY	2015-09-24
PMA P100033S005 GEN-PROBE INCORPORATED	PROGENSA PCA3 ASSAY	2015-07-09
PMA P120007S003 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 GENOTYPE ASSAY	2015-06-05
PMA P100042S004 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2015-06-05
PMA P100033S003 GEN-PROBE INCORPORATED	PROGENSA PCA3 ASSAY	2015-04-16
PMA P120007S004 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 GENOTYPE ASSAY	2015-04-01
PMA P100042S005 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2015-04-01
PMA P100033S002 GEN-PROBE INCORPORATED	PROGENSA PCA3 ASSAY	2015-01-21
PMA P100042S003 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2014-07-07
PMA P120007S002 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 GENETYPE ASSAY	2014-04-29
PMA P100042S002 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2014-04-29
PMA P100033S001 GEN-PROBE INCORPORATED	PROGENSA PCA3 ASSAY	2013-12-12
PMA P120007S001 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 GENOTYPE ASSAY	2013-11-06
PMA P100042S001 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2013-07-15
PMN K122062 GEN-PROBE, INC.	APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER	2013-01-09
PMA P940034S019 GEN-PROBE, INC.	AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST	2012-12-05
PMA P120007 GEN-PROBE INCORPORATED	APTIMA HPV 16 18/45 GENOTYPE ASSAY	2012-10-12
PMN K111409 GEN-PROBE, INC.	APTIMA COMBO 2 ASSAY	2012-05-03
PMA P100033 GEN-PROBE INCORPORATED	PROGENSA PCA3 ASSAY	2012-02-13
PMA P100042 GEN-PROBE INCORPORATED	APTIMA HPV ASSAY	2011-10-28
De Novo DEN110012 GEN-PROBE INCORPORATED	APTIMA TRICHOMONAS VAGINALIS ASSAY	2011-04-19
PMA P940034S018 GEN-PROBE, INC.	AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST	2010-04-23
PMA P940034S017 GEN-PROBE, INC.	GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)	2007-07-18
PMN K063664 GEN-PROBE, INC.	GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091	2007-01-25
PMN K063451 GEN-PROBE, INC.	GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199	2007-01-22
PMN K062440 GEN-PROBE, INC.	GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091	2006-11-07
PMN K061413 GEN-PROBE, INC.	APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM	2006-10-13
PMN K061509 GEN-PROBE, INC.	TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196	2006-10-04
PMN K060652 GEN-PROBE, INC.	TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY	2006-08-17
PMN K053446 GEN-PROBE, INC.	GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088	2006-07-25
PMN K043224 GEN-PROBE, INC.	GEN-PROBE APTIMA COMBO 2 ASSAY	2005-08-09
PMN K043144 GEN-PROBE, INC.	GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE	2005-03-14
PMN K043072 GEN-PROBE, INC.	GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS	2005-01-27
PMA P940034S016 GEN-PROBE, INC.	GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST	2004-10-08
PMA P940034S015 GEN-PROBE, INC.	GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST	2004-02-10
PMN K032554 GEN-PROBE, INC.	GEN-PROBE APTIMA COMBO 2 ASSAY	2003-12-31
PMN K032194 GEN-PROBE, INC.	TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS	2003-12-24
PMN K022874 GEN-PROBE, INC.	GEN-PROBE APTIMA COMBO 2 ASSAY	2002-09-17
PMA P940034S013 GEN-PROBE, INC.	GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST)	2002-01-25
PMA P940034S012 GEN-PROBE, INC.	GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST	2001-08-30
PMN K003395 GEN-PROBE, INC.	GEN-PROBE APTIMA COMBO 2 ASSAY	2001-05-21
PMA P940034S011 GEN-PROBE, INC.	GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)	2000-11-21
PMA P940034S008 GEN-PROBE, INC.	GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST	1999-09-30
PMA P940034S007 GEN-PROBE, INC.	GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)	1999-09-02
PMA P940034S010 GEN-PROBE, INC.	GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST	1999-05-25
PMA P940034S009 GEN-PROBE, INC.	AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST	1998-12-01
PMA P940034S004 GEN-PROBE, INC.	GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)	1998-05-15
PMA P940034S005 GEN-PROBE, INC.	GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)	1998-01-07
PMA P940034S006 GEN-PROBE, INC.	GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)	1997-10-30
PMN K962217 GEN-PROBE, INC.	GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT	1996-11-27
PMA P940034S003 GEN-PROBE, INC.	GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)	1996-08-22
PMA P940034S002 GEN-PROBE, INC.	GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)	1996-06-05
PMA P940034S001 GEN-PROBE, INC.	GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)	1996-04-23
PMA P940034 GEN-PROBE, INC.	GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)	1995-12-15
PMN K940979 GEN-PROBE, INC.	GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR	1994-10-31
PMN K920301 GEN-PROBE, INC.	PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY	1994-04-26
PMN K920302 GEN-PROBE, INC.	PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY	1994-04-06
PMN K924715 GEN-PROBE, INC.	GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST	1994-03-11
PMN K921435 GEN-PROBE, INC.	ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE	1992-07-23
PMN K920378 GEN-PROBE, INC.	PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS	1992-04-29
PMN K915852 GEN-PROBE, INC.	ACCUPACE GROUP A STREPTOCOCCUS ID TEST	1992-04-02
PMN K905762 GEN-PROBE, INC.	GEN-PROBE LUMINOMETER-LEADER 450	1991-01-23
PMN K904463 GEN-PROBE, INC.	ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST	1990-11-13
PMN K904268 GEN-PROBE, INC.	ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.	1990-11-13
PMN K903911 GEN-PROBE, INC.	GEN-PROBE PAL LUMINOMETER	1990-10-04
PMN K904047 GEN-PROBE, INC.	ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.	1990-10-02
PMN K903556 GEN-PROBE, INC.	ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST	1990-10-02
PMN K903934 GEN-PROBE, INC.	GEN-PROBE LUMINOMETER-LEADER 50	1990-09-27
PMN K903201 GEN-PROBE, INC.	ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST	1990-09-12
PMN K897077 GEN-PROBE, INC.	ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE	1990-08-23
PMN K896494 GEN-PROBE, INC.	ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST	1990-08-23
PMN K902908 GEN-PROBE, INC.	ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.	1990-08-06
PMN K902213 GEN-PROBE, INC.	ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.	1990-08-06
PMN K901397 GEN-PROBE, INC.	ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.	1990-06-20
PMN K897078 GEN-PROBE, INC.	ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE	1990-05-02
PMN K896492 GEN-PROBE, INC.	ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST	1990-04-16
PMN K896493 GEN-PROBE, INC.	ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST	1990-04-11
PMN K897079 GEN-PROBE, INC.	ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE	1990-03-08
PMN K896859 GEN-PROBE, INC.	ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST	1990-02-01
PMN K895103 GEN-PROBE, INC.	ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION	1989-11-29
PMN K895583 GEN-PROBE, INC.	ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.	1989-11-14
PMN K894712 GEN-PROBE, INC.	ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION	1989-11-14
PMN K894711 GEN-PROBE, INC.	ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.	1989-11-14
PMN K892216 GEN-PROBE, INC.	GEN-PROBE PACE SYSTEM URINE SCREEN	1989-09-15
PMN K890089 GEN-PROBE, INC.	RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE	1989-03-13
PMN K881277 GEN-PROBE, INC.	PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS	1988-04-25
PMN K874620 GEN-PROBE, INC.	GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE	1988-03-01
PMN K874878 GEN-PROBE, INC.	GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS	1987-12-29
PMN K871878 GEN-PROBE, INC.	RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS	1987-10-28
PMN K872219 GEN-PROBE, INC.	GEN-PROBE (R) LUMINOMETER - LEADER (TM)	1987-08-21
PMN K871795 GEN-PROBE, INC.	RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.	1987-07-30
PMN K870422 GEN-PROBE, INC.	GEN-PROBE BETA-LACTAMASE TEST KIT	1987-04-21
PMN K864597 GEN-PROBE, INC.	GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA	1987-04-20
PMN K862614 GEN-PROBE, INC.	RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX	1986-11-10
PMN K862613 GEN-PROBE, INC.	RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX	1986-11-10
PMN K860498 GEN-PROBE, INC.	GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM	1986-07-16
PMN K860574 GEN-PROBE, INC.	GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM	1986-07-03
PMN K860782 GEN-PROBE, INC.	GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM	1986-07-02
PMN K851271 GEN-PROBE, INC.	LEGIONELLA CULTURE CONFIRMATIN KIT	1985-07-08

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Related Finance Registrations

CAGE Code	0BDV3	GEN-PROBE INCORPORATED GEN-PROBE SALES & SERVICES, INC.
S.A.M. Registration	0BDV3 [115337123]	GEN-PROBE INCORPORATED
SEC	0000820237	GEN PROBE INC of DELAWARE