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 Registration(s)

FDA Filings

Device
Company
DeviceDate
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2020-06-11
GEN-PROBE INCORPORATED
Aptima HPV Assay2020-06-11
GEN-PROBE INCORPORATED
Progensa PCA3 Assay2020-06-08
GEN-PROBE INCORPORATED
Aptima HPV Assay2020-02-10
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2020-01-21
GEN-PROBE INCORPORATED
Aptima HPV Assay2020-01-21
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2019-09-16
GEN-PROBE INCORPORATED
Aptima HPV Assay2019-09-16
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2019-08-27
GEN-PROBE INCORPORATED
Aptima HPV Assay2019-08-27
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 Genotype Assay2019-04-28
GEN-PROBE INCORPORATED
APTIMA HPV Assay2019-04-28
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 Genotype Assay2019-04-26
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2019-04-26
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2019-04-22
GEN-PROBE INCORPORATED
Aptima HPV Assay2019-03-21
GEN-PROBE INCORPORATED
Progensa PCA3 Assay2019-03-15
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2019-02-28
GEN-PROBE INCORPORATED
Aptima HPV Assay2019-02-28
GEN-PROBE INCORPORATED
Progensa PCA3 Assay2018-10-18
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2018-09-28
GEN-PROBE INCORPORATED
Aptima HPV Assay2018-09-28
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2018-09-13
GEN-PROBE INCORPORATED
Aptima HPV Assay2018-09-13
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2018-04-13
GEN-PROBE INCORPORATED
Aptima HPV Assay2018-04-13
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2018-03-08
GEN-PROBE INCORPORATED
Aptima HPV Assay2018-03-08
GEN-PROBE INCORPORATED
Progensa PCA3 Assay2018-03-07
GEN-PROBE INCORPORATED
Aptima HPV Assay2018-02-28
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2018-02-23
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2018-01-18
GEN-PROBE INCORPORATED
Aptima HPV Assay2018-01-18
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2017-11-03
GEN-PROBE INCORPORATED
Aptima HPV Assay2017-11-03
GEN-PROBE INCORPORATED
Progensa PCA3 Assay2017-11-03
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay.2017-05-04
GEN-PROBE INCORPORATED
Aptima HPV Assay2017-05-04
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 GENOTYPE ASSAY2016-09-19
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2016-09-19
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 GENOTYPE ASSAY2016-09-13
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2016-09-13
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2016-05-20
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 GENOTYPE ASSAY2016-03-28
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2015-11-24
GEN-PROBE INCORPORATED
PROGENSA PCA3 ASSAY2015-11-12
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 GENOTYPE ASSAY2015-11-09
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2015-11-09
GEN-PROBE INCORPORATED
PROGENSA PCA3 ASSAY2015-09-24
GEN-PROBE INCORPORATED
PROGENSA PCA3 ASSAY2015-07-09
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 GENOTYPE ASSAY2015-06-05
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2015-06-05
GEN-PROBE INCORPORATED
PROGENSA PCA3 ASSAY2015-04-16
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 GENOTYPE ASSAY2015-04-01
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2015-04-01
GEN-PROBE INCORPORATED
PROGENSA PCA3 ASSAY2015-01-21
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2014-07-07
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 GENETYPE ASSAY2014-04-29
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2014-04-29
GEN-PROBE INCORPORATED
PROGENSA PCA3 ASSAY2013-12-12
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 GENOTYPE ASSAY2013-11-06
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2013-07-15
GEN-PROBE, INC.
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER2013-01-09
GEN-PROBE, INC.
AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST2012-12-05
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 GENOTYPE ASSAY2012-10-12
GEN-PROBE, INC.
APTIMA COMBO 2 ASSAY2012-05-03
GEN-PROBE INCORPORATED
PROGENSA PCA3 ASSAY2012-02-13
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2011-10-28
GEN-PROBE, INC.
AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST2010-04-23
GEN-PROBE, INC.
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)2007-07-18
GEN-PROBE, INC.
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#10912007-01-25
GEN-PROBE, INC.
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 11992007-01-22
GEN-PROBE, INC.
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 10912006-11-07
GEN-PROBE, INC.
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 11962006-10-04
GEN-PROBE, INC.
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY2006-08-17
GEN-PROBE, INC.
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 10882006-07-25
GEN-PROBE, INC.
GEN-PROBE APTIMA COMBO 2 ASSAY2005-08-09
GEN-PROBE, INC.
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE2005-03-14
GEN-PROBE, INC.
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS2005-01-27
GEN-PROBE, INC.
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST2004-10-08
GEN-PROBE, INC.
GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST2004-02-10
GEN-PROBE, INC.
GEN-PROBE APTIMA COMBO 2 ASSAY2003-12-31
GEN-PROBE, INC.
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS2003-12-24
GEN-PROBE, INC.
GEN-PROBE APTIMA COMBO 2 ASSAY2002-09-17
GEN-PROBE, INC.
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST)2002-01-25
GEN-PROBE, INC.
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST2001-08-30
GEN-PROBE, INC.
GEN-PROBE APTIMA COMBO 2 ASSAY2001-05-21
GEN-PROBE, INC.
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)2000-11-21
GEN-PROBE, INC.
GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST1999-09-30
GEN-PROBE, INC.
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)1999-09-02
GEN-PROBE, INC.
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST1999-05-25
GEN-PROBE, INC.
AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST1998-12-01
GEN-PROBE, INC.
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)1998-05-15
GEN-PROBE, INC.
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)1998-01-07
GEN-PROBE, INC.
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)1997-10-30
GEN-PROBE, INC.
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT1996-11-27
GEN-PROBE, INC.
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)1996-08-22
GEN-PROBE, INC.
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)1996-06-05
GEN-PROBE, INC.
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)1996-04-23
GEN-PROBE, INC.
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)1995-12-15
GEN-PROBE, INC.
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR1994-10-31
GEN-PROBE, INC.
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY1994-04-26
GEN-PROBE, INC.
PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY1994-04-06
GEN-PROBE, INC.
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST1994-03-11
GEN-PROBE, INC.
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE1992-07-23
GEN-PROBE, INC.
PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS1992-04-29
GEN-PROBE, INC.
ACCUPACE GROUP A STREPTOCOCCUS ID TEST1992-04-02
GEN-PROBE, INC.
GEN-PROBE LUMINOMETER-LEADER 4501991-01-23
GEN-PROBE, INC.
ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST1990-11-13
GEN-PROBE, INC.
ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.1990-11-13
GEN-PROBE, INC.
GEN-PROBE PAL LUMINOMETER1990-10-04
GEN-PROBE, INC.
ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.1990-10-02
GEN-PROBE, INC.
ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST1990-10-02
GEN-PROBE, INC.
GEN-PROBE LUMINOMETER-LEADER 501990-09-27
GEN-PROBE, INC.
ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST1990-09-12
GEN-PROBE, INC.
ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE1990-08-23
GEN-PROBE, INC.
ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST1990-08-23
GEN-PROBE, INC.
ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.1990-08-06
GEN-PROBE, INC.
ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.1990-08-06
GEN-PROBE, INC.
ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.1990-06-20
GEN-PROBE, INC.
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE1990-05-02
GEN-PROBE, INC.
ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST1990-04-16
GEN-PROBE, INC.
ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST1990-04-11
GEN-PROBE, INC.
ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE1990-03-08
GEN-PROBE, INC.
ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST1990-02-01
GEN-PROBE, INC.
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION1989-11-29
GEN-PROBE, INC.
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.1989-11-14
GEN-PROBE, INC.
ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION1989-11-14
GEN-PROBE, INC.
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.1989-11-14
GEN-PROBE, INC.
GEN-PROBE PACE SYSTEM URINE SCREEN1989-09-15
GEN-PROBE, INC.
RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE1989-03-13
GEN-PROBE, INC.
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS1988-04-25
GEN-PROBE, INC.
GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE1988-03-01
GEN-PROBE, INC.
GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS1987-12-29
GEN-PROBE, INC.
RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS1987-10-28
GEN-PROBE, INC.
GEN-PROBE (R) LUMINOMETER - LEADER (TM)1987-08-21
GEN-PROBE, INC.
RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.1987-07-30
GEN-PROBE, INC.
GEN-PROBE BETA-LACTAMASE TEST KIT1987-04-21
GEN-PROBE, INC.
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA1987-04-20
GEN-PROBE, INC.
RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX1986-11-10
GEN-PROBE, INC.
RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX1986-11-10
GEN-PROBE, INC.
GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM1986-07-16
GEN-PROBE, INC.
GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM1986-07-03
GEN-PROBE, INC.
GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM1986-07-02
GEN-PROBE, INC.
LEGIONELLA CULTURE CONFIRMATIN KIT1985-07-08

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