LSL · Class II · 21 CFR 866.3390

FDA Product Code LSL: Dna-reagents, Neisseria

Leading manufacturers include Gen-Probe, Inc., Becton, Dickinson & CO and Roche Molecular Systems, Inc..

45
Total
45
Cleared
215d
Avg days
1987
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Dna-reagents, Neisseria Devices (Product Code LSL)

45 devices
1–24 of 45
Cleared Jan 26, 2024
Aptima Neisseria gonorrhoeae Assay
K231329
Hologic, Inc.
Microbiology · 263d
Cleared Jun 13, 2018
Aptima Combo 2 Assay (Panther System)
K180681
Hologic, Inc.
Microbiology · 90d
Cleared Mar 21, 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887
Roche Molecular Systems, Inc.
Microbiology · 90d
Cleared Mar 16, 2018
Xpert CT/NG
K173840
Cepheid
Microbiology · 88d
Cleared Feb 09, 2017
cobas® CT/NG v2.0 Test
K163184
Roche Molecular Systems, Inc.
Microbiology · 87d
Cleared May 20, 2014
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K140448
Becton, Dickinson & CO
Microbiology · 88d
Cleared May 05, 2014
COBAS CT/NG V2.0 TEST
K140887
Roche Molecular Systems, Inc.
Microbiology · 28d
Cleared Dec 02, 2013
COBAS CT/NG V2.0 TEST
K132270
Roche Molecular Systems, Inc.
Microbiology · 133d
Cleared Dec 27, 2012
XPERT CT/NG
K121710
Cepheid
Microbiology · 199d
Cleared May 03, 2012
APTIMA COMBO 2 ASSAY
K111409
Gen-Probe, Inc.
Microbiology · 350d
Cleared Nov 13, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K091730
Becton, Dickinson & CO
Microbiology · 155d
Cleared Jun 05, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090971
Becton, Dickinson & CO
Microbiology · 60d
Cleared May 27, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090827
Becton, Dickinson & CO
Microbiology · 62d
Cleared Dec 11, 2008
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY
K081825
Becton, Dickinson & CO
Microbiology · 167d
Cleared Jan 25, 2007
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091
K063664
Gen-Probe, Inc.
Microbiology · 48d
Cleared Nov 07, 2006
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
K062440
Gen-Probe, Inc.
Microbiology · 78d
Cleared Oct 04, 2006
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
K061509
Gen-Probe, Inc.
Microbiology · 125d
Cleared Aug 17, 2006
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
K060652
Gen-Probe, Inc.
Microbiology · 157d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K053289
Roche Diagnostics Corp.
Microbiology · 258d
Cleared Nov 28, 2005
BD VIPER SYSTEM
K052481
Becton, Dickinson & CO
Microbiology · 80d
Cleared Sep 12, 2005
BD PROBE TEC URINE PRESERVATIVE TRANSPORT
K052224
Becton, Dickinson & CO
Microbiology · 27d
Cleared Aug 09, 2005
GEN-PROBE APTIMA COMBO 2 ASSAY
K043224
Gen-Probe, Inc.
Microbiology · 260d
Cleared Mar 14, 2005
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
K043144
Gen-Probe, Inc.
Microbiology · 119d
Cleared Dec 31, 2003
GEN-PROBE APTIMA COMBO 2 ASSAY
K032554
Gen-Probe, Inc.
Microbiology · 134d

About Product Code LSL - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code LSL since 1987, with 45 receiving FDA clearance (average review time: 215 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.