FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K935833 |
ABBOTT LABORATORIES |
LCX NEISSERIA GONORRHOEAE ASSAY |
05/06/1996 |
K140354 |
ABBOTT MOLECULAR, INC. |
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG |
05/09/2014 |
K012351 |
BECTON DICKINSON & CO. |
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY |
09/18/2001 |
K984631 |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY |
11/04/1999 |
K052224 |
BECTON, DICKINSON & CO. |
BD PROBE TEC URINE PRESERVATIVE TRANSPORT |
09/12/2005 |
K081825 |
BECTON, DICKINSON & CO. |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY |
12/11/2008 |
K090827 |
BECTON, DICKINSON & CO. |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY |
05/27/2009 |
K090971 |
BECTON, DICKINSON & CO. |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY |
06/05/2009 |
K091730 |
BECTON, DICKINSON & CO. |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY |
11/13/2009 |
K140448 |
BECTON, DICKINSON & CO. |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY |
05/20/2014 |
K052481 |
BECTON, DICKINSON & CO. |
BD VIPER SYSTEM |
11/28/2005 |
K121710 |
CEPHEID |
XPERT CT/NG |
12/27/2012 |
K173840 |
Cepheid |
Xpert CT/NG |
03/16/2018 |
K981567 |
DIGENE CORP. |
HYBRID CAPTURE II CT/GC TEST |
02/29/2000 |
K981485 |
DIGENE CORP. |
HYBRID CAPTURE II GC-ID |
11/29/1999 |
K010893 |
DIGENE CORP. |
MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 |
09/24/2001 |
K111409 |
GEN-PROBE, INC. |
APTIMA COMBO 2 ASSAY |
05/03/2012 |
K043144 |
GEN-PROBE, INC. |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE |
03/14/2005 |
K063664 |
GEN-PROBE, INC. |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 |
01/25/2007 |
K062440 |
GEN-PROBE, INC. |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 |
11/07/2006 |
K003395 |
GEN-PROBE, INC. |
GEN-PROBE APTIMA COMBO 2 ASSAY |
05/21/2001 |
K032554 |
GEN-PROBE, INC. |
GEN-PROBE APTIMA COMBO 2 ASSAY |
12/31/2003 |
K043224 |
GEN-PROBE, INC. |
GEN-PROBE APTIMA COMBO 2 ASSAY |
08/09/2005 |
K032194 |
GEN-PROBE, INC. |
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS |
12/24/2003 |
K061509 |
GEN-PROBE, INC. |
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 |
10/04/2006 |
K060652 |
GEN-PROBE, INC. |
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY |
08/17/2006 |
K132251 |
HOLOGIC / GEN-PROBE INCORPORATED |
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) |
10/17/2013 |
K180681 |
Hologic, Inc. |
Aptima Combo 2 Assay (Panther System) |
06/13/2018 |
K053289 |
ROCHE DIAGNOSTICS CORP. |
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
08/10/2006 |
K070172 |
ROCHE DIAGNOSTICS CORPORATION |
AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
04/17/2007 |
K173887 |
Roche Molecular Systems, Inc. |
cobas CT/NG for use on cobas 6800/8800 systems |
03/21/2018 |
K132270 |
ROCHE MOLECULAR SYSTEMS, INC. |
COBAS CT/NG V2.0 TEST |
12/02/2013 |
K140887 |
ROCHE MOLECULAR SYSTEMS, INC. |
COBAS CT/NG V2.0 TEST |
05/05/2014 |
K163184 |
Roche Molecular Systems, Inc. |
cobas« CT/NG v2.0 Test |
02/09/2017 |
K974503 |
ROCHE MOLECULAR SYSTEMS, INC. |
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
12/01/1999 |
K974342 |
ROCHE MOLECULAR SYSTEMS, INC. |
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
05/28/1999 |
K991268 |
SIERRA DIAGNOSTICS |
GONOSTAT GONOCOCCAL DETECTION KIT |
08/11/1999 |