Panels › Microbiology › Product code LSL · Class 2
Dna-Reagents, Neisseria
Regulation 866.3390
0510(k)s in 12 months (45 all time)
0recalls in 12 months (7 all time)
5recalls that name a 510(k)
Top companies in LSL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 26, 2024 | K231329 | Aptima Neisseria gonorrhoeae Assay Hologic, Inc. | LSL |
| Jun 13, 2018 | K180681 | Aptima Combo 2 Assay (Panther System) Hologic, Inc. | LSL |
| Mar 21, 2018 | K173887 | cobas CT/NG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc. | LSL |
| Mar 16, 2018 | K173840 | Xpert CT/NG Cepheid | LSL |
| Feb 9, 2017 | K163184 | cobas® CT/NG v2.0 Test Roche Molecular Systems, Inc. | LSL |
| May 20, 2014 | K140448 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| May 9, 2014 | K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG Abbott Molecular, Inc. | LSL |
| May 5, 2014 | K140887 | COBAS CT/NG V2.0 TEST Roche Molecular Systems, Inc. | LSL |
| Dec 2, 2013 | K132270 | COBAS CT/NG V2.0 TEST Roche Molecular Systems, Inc. | LSL |
| Oct 17, 2013 | K132251 | APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) Hologic / Gen-Probe Incorporated | LSL |
| Dec 27, 2012 | K121710 | XPERT CT/NG Cepheid | LSL |
| May 3, 2012 | K111409 | APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | LSL |
| Nov 13, 2009 | K091730 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| Jun 5, 2009 | K090971 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| May 27, 2009 | K090827 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| Dec 11, 2008 | K081825 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| Apr 17, 2007 | K070172 | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE Roche Diagnostics Corporation | LSL |
| Jan 25, 2007 | K063664 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 Gen-Probe, Inc. | LSL |
| Nov 7, 2006 | K062440 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 Gen-Probe, Inc. | LSL |
| Oct 4, 2006 | K061509 | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 Gen-Probe, Inc. | LSL |
| Aug 17, 2006 | K060652 | TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | LSL |
| Aug 10, 2006 | K053289 | COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE Roche Diagnostics Corp. | LSL |
| Nov 28, 2005 | K052481 | BD VIPER SYSTEM Becton, Dickinson & CO | LSL |
| Sep 12, 2005 | K052224 | BD PROBE TEC URINE PRESERVATIVE TRANSPORT Becton, Dickinson & CO | LSL |
| Aug 9, 2005 | K043224 | GEN-PROBE APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | LSL |
| Mar 14, 2005 | K043144 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE Gen-Probe, Inc. | LSL |
| Dec 31, 2003 | K032554 | GEN-PROBE APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | LSL |
| Dec 24, 2003 | K032194 | TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS Gen-Probe, Inc. | LSL |
| Sep 24, 2001 | K010893 | MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 Digene Corp. | LSL |
| Sep 18, 2001 | K012351 | BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY Becton, Dickinson & CO | LSL |
| May 21, 2001 | K003395 | GEN-PROBE APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | LSL |
| Feb 29, 2000 | K981567 | HYBRID CAPTURE II CT/GC TEST Digene Corp. | LSL |
| Dec 1, 1999 | K974503 | ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE Roche Molecular Systems, Inc. | LSL |
| Nov 29, 1999 | K981485 | HYBRID CAPTURE II GC-ID Digene Corp. | LSL |
| Nov 4, 1999 | K984631 | BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY Becton Dickinson Microbiology Systems | LSL |
| Aug 11, 1999 | K991268 | GONOSTAT GONOCOCCAL DETECTION KIT Sierra Diagnostics | LSL |
| May 28, 1999 | K974342 | ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE Roche Molecular Systems, Inc. | LSL |
| May 6, 1996 | K935833 | LCX NEISSERIA GONORRHOEAE ASSAY Abbott Laboratories | LSL |
| Oct 31, 1994 | K940979 | GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR Gen-Probe, Inc. | LSL |
| Apr 26, 1994 | K920301 | PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY Gen-Probe, Inc. | LSL |
| Nov 14, 1989 | K895583 | ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA. Gen-Probe, Inc. | LSL |
| Aug 15, 1989 | K883486 | GONOSTAT Technology Management & Marketing, Inc. | LSL |
| Apr 25, 1988 | K881277 | PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS Gen-Probe, Inc. | LSL |
| Mar 1, 1988 | K874620 | GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE Gen-Probe, Inc. | LSL |
| Dec 21, 1987 | K872628 | GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST Ortho Diagnostic Systems, Inc. | LSL |
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