Gen-Probe

PMA#

Aptima HPV 16 18/45 Genotype Assay
2022-02-25
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 ...
Aptima HPV Assay
2022-01-28
GEN-PROBE INCORPORATED
Aptima HCV RNA Qualitative Assay
2020-07-21
GEN-PROBE
Progensa PCA3 Assay
2020-07-21
GEN-PROBE INCORPORATED
Aptima HPV Assay
2020-07-21
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2020-07-21
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2020-06-11
GEN-PROBE INCORPORATED
Aptima HPV Assay
2020-06-11
GEN-PROBE INCORPORATED
Progensa PCA3 Assay
2020-06-08
GEN-PROBE INCORPORATED
Aptima HCV RNA Qualitative Assay
2020-02-14
GEN-PROBE
Aptima HPV Assay
2020-02-10
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2020-01-21
GEN-PROBE INCORPORATED
Aptima HPV Assay
2020-01-21
GEN-PROBE INCORPORATED
Aptima HPV Assay
2019-09-16
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2019-09-16
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2019-08-27
GEN-PROBE INCORPORATED
Aptima HPV Assay
2019-08-27
GEN-PROBE INCORPORATED
Aptima HCV RNA Qualitative Assay
2019-06-21
GEN-PROBE
APTIMA HPV Assay
2019-04-28
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 Genotype Assay
2019-04-28
GEN-PROBE INCORPORATED
APTIMA HCV RNA Qualitative Assay
2019-04-26
GEN-PROBE
APTIMA HPV ASSAY
2019-04-26
GEN-PROBE INCORPORATED
APTIMA HPV 16 18/45 Genotype Assay
2019-04-26
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2019-04-22
GEN-PROBE INCORPORATED
Aptima HCV RNA Qualitative Assay
2019-03-21
GEN-PROBE
Aptima HPV Assay
2019-03-21
GEN-PROBE INCORPORATED
Progensa PCA3 Assay
2019-03-15
GEN-PROBE INCORPORATED
Aptima HPV Assay
2019-02-28
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2019-02-28
GEN-PROBE INCORPORATED
Aptima HCV RNA Qualitative Assay
2018-10-31
GEN-PROBE
Progensa PCA3 Assay
2018-10-18
GEN-PROBE INCORPORATED
Aptima HPV Assay
2018-09-28
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2018-09-28
GEN-PROBE INCORPORATED
Aptima HPV Assay
2018-09-13
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2018-09-13
GEN-PROBE INCORPORATED
Aptima HPV Assay
2018-04-13
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2018-04-13
GEN-PROBE INCORPORATED
Aptima HPV Assay
2018-03-08
GEN-PROBE INCORPORATED
Aptima HPV 16 18/45 Genotype Assay
2018-03-08
GEN-PROBE INCORPORATED
Progensa PCA3 Assay
2018-03-07
GEN-PROBE INCORPORATED

106 records. Showing 1-40. Next

PMN#

PRODESSE PROFAST+ ASSAY
2013-08-26
GEN-PROBE PRODESSE, INC.
PROPARAFLU+ ASSAY
2013-08-26
GEN-PROBE PRODESSE, INC.
PRO HMPV+ ASSAY
2013-08-14
GEN-PROBE PRODESSE, INC
PROADENO+ ASSAY
2013-08-14
GEN-PROBE PRODESSE, INC
PRODESSE PROFLU+ ASSAY
2013-08-09
GEN-PROBE PRODESSE, INC.
PRO HMPV+ ASSAY
2013-01-16
GEN-PROBE PRODESSE, INC.
PROGASTRO SSCS ASSAY
2013-01-16
GEN-PROBE PRODESSE, INC.
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
2013-01-09
GEN-PROBE, INC.
Qualitative Test For HLA, Non-diagnostic
2012-11-21
Gen-Probe
Qualitative Test For HLA, Non-diagnostic
2012-06-04
Gen-Probe GTI Diagnostics
APTIMA COMBO 2 ASSAY
2012-05-03
GEN-PROBE, INC.
Qualitative Test For HLA, Non-diagnostic
2011-12-02
Gen-Probe
PROFLU+ ASSAY
2011-06-27
GEN-PROBE PRODESSE, INC
PRODESSE PROADENO
2010-12-03
GEN-PROBE PRODESSE, INC
PROFAST+ ASSAY
2010-07-23
GEN-PROBE PRODESSE, INC
Automated Bloodborne Pathogen Test Equipment
2007-02-20
Gen-Probe
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091
2007-01-25
GEN-PROBE, INC.
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199
2007-01-22
GEN-PROBE, INC.
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
2006-11-07
GEN-PROBE, INC.
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
2006-10-13
GEN-PROBE, INC.
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
2006-10-04
GEN-PROBE, INC.
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
2006-08-17
GEN-PROBE, INC.
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
2006-07-25
GEN-PROBE, INC.
Platelet Antibody Test
2006-01-20
Gen-Probe GTI Diagnostics
GEN-PROBE APTIMA COMBO 2 ASSAY
2005-08-09
GEN-PROBE, INC.
Automated Bloodborne Pathogen Test Equipment
2005-04-29
Gen-Probe
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
2005-03-14
GEN-PROBE, INC.
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
2005-01-27
GEN-PROBE, INC.
Qualitative Test For HLA, Non-diagnostic
2004-07-16
Gen-Probe GTI Diagnostics
GEN-PROBE APTIMA COMBO 2 ASSAY
2003-12-31
GEN-PROBE, INC.
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
2003-12-24
GEN-PROBE, INC.
GEN-PROBE APTIMA COMBO 2 ASSAY
2002-09-17
GEN-PROBE, INC.
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
Gen-Probe
GEN-PROBE APTIMA COMBO 2 ASSAY
2001-05-21
GEN-PROBE, INC.
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
1996-11-27
GEN-PROBE, INC.
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
1994-10-31
GEN-PROBE, INC.
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY
1994-04-26
GEN-PROBE, INC.
PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY
1994-04-06
GEN-PROBE, INC.
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST
1994-03-11
GEN-PROBE, INC.
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
1992-07-23
GEN-PROBE, INC.

80 records. Showing 1-40. Next