GEN-PROBE INCORPORATED

FDA Filings

This page includes the latest FDA filings for GEN-PROBE INCORPORATED. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
GEN-PROBE PRODESSE, INC.
PRODESSE PROFAST+ ASSAY2013-08-26
GEN-PROBE PRODESSE, INC.
PROPARAFLU+ ASSAY2013-08-26
GEN-PROBE PRODESSE, INC
PROADENO+ ASSAY2013-08-14
GEN-PROBE PRODESSE, INC
PRO HMPV+ ASSAY2013-08-14
GEN-PROBE PRODESSE, INC.
PRODESSE PROFLU+ ASSAY2013-08-09
GEN-PROBE PRODESSE, INC.
Pro Hmpv+ Assay2013-01-16
GEN-PROBE PRODESSE, INC.
PROGASTRO SSCS ASSAY2013-01-16
GEN-PROBE, INC.
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER2013-01-09
Gen-Probe
Qualitative Test For Hla, Non-diagnostic: LIFECODES HLA-C ERES Typing Kit For Use With Luminex2012-11-21
Gen-Probe GTI Diagnostics
Qualitative Test For Hla, Non-diagnostic: Lifecodes Class II ID V22012-06-04
GEN-PROBE, INC.
APTIMA COMBO 2 ASSAY2012-05-03
Gen-Probe
Qualitative Test For Hla, Non-diagnostic: LIFECODES HLA-A ERES Typing Kit For Use With Luminex2011-12-02
GEN-PROBE PRODESSE, INC
PROFLU+ ASSAY2011-06-27
GEN-PROBE PRODESSE, INC
PRODESSE PROADENO2010-12-03
GEN-PROBE PRODESSE, INC
PROFAST+ ASSAY2010-07-23
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 COMBO 2 ASSAY2002-09-17
GEN-PROBE, INC.
GEN-PROBE APTIMA COMBO 2 ASSAY2001-05-21
GEN-PROBE, INC.
Gen-probe Amplified Chlamydia Trachomatis Assay Kit1996-11-27
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 Streptococcus Pyogenes Culture Confirm.1990-11-13

Latest Premarket Applications

PMAManufacturerDevice NameDate
GEN-PROBE
Aptima HCV RNA Qualitative Assay2020-02-14
GEN-PROBE INCORPORATED
Aptima HPV Assay2020-02-10
GEN-PROBE INCORPORATED
Aptima HPV Assay2020-01-21
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype 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
Aptima HCV RNA Qualitative Assay2019-06-21
GEN-PROBE INCORPORATED
APTIMA HPV Assay2019-04-28
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 Genotype Assay2019-04-28
GEN-PROBE INCORPORATED
APTIMA HPV ASSAY2019-04-26
GEN-PROBE
APTIMA HCV RNA Qualitative Assay2019-04-26
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 Genotype 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
Aptima HCV RNA Qualitative 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
Aptima HCV RNA Qualitative Assay2018-10-31
GEN-PROBE INCORPORATED
Progensa PCA3 Assay2018-10-18
GEN-PROBE INCORPORATED
Aptima HPV Assay2018-09-28
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype 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 Assay2018-04-13
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2018-04-13
GEN-PROBE INCORPORATED
Aptima HPV Assay2018-03-08
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay2018-03-08

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate

Related Finance Registrations

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