Product code LSL
- Device name
- Dna-Reagents, Neisseria
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3390
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231329 | Aptima Neisseria gonorrhoeae Assay | Hologic, Inc. | 2024-01-26 |
| K180681 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | 2018-06-13 |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2018-03-21 |
| K173840 | Xpert CT/NG | Cepheid | 2018-03-16 |
| K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | 2017-02-09 |
| K140448 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2014-05-20 |
| K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | Abbott Molecular, Inc. | 2014-05-09 |
| K140887 | COBAS CT/NG V2.0 TEST | Roche Molecular Systems, Inc. | 2014-05-05 |
| K132270 | COBAS CT/NG V2.0 TEST | Roche Molecular Systems, Inc. | 2013-12-02 |
| K132251 | APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) | Hologic / Gen-Probe Incorporated | 2013-10-17 |
| K121710 | XPERT CT/NG | Cepheid | 2012-12-27 |
| K111409 | APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2012-05-03 |
| K091730 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2009-11-13 |
| K090971 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2009-06-05 |
| K090827 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2009-05-27 |
| K081825 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2008-12-11 |
| K070172 | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Diagnostics Corporation | 2007-04-17 |
| K063664 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 | Gen-Probe, Inc. | 2007-01-25 |
| K062440 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 | Gen-Probe, Inc. | 2006-11-07 |
| K061509 | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 | Gen-Probe, Inc. | 2006-10-04 |
| K060652 | TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2006-08-17 |
| K053289 | COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Diagnostics Corp. | 2006-08-10 |
| K052481 | BD VIPER SYSTEM | Becton, Dickinson & CO | 2005-11-28 |
| K052224 | BD PROBE TEC URINE PRESERVATIVE TRANSPORT | Becton, Dickinson & CO | 2005-09-12 |
| K043224 | GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2005-08-09 |
| K043144 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE | Gen-Probe, Inc. | 2005-03-14 |
| K032554 | GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2003-12-31 |
| K032194 | TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS | Gen-Probe, Inc. | 2003-12-24 |
| K010893 | MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 | Digene Corp. | 2001-09-24 |
| K012351 | BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2001-09-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00875197007275 | cobas® liat CT/NG | Roche Molecular Systems, Inc. | 2026-02-24 |
| 00875197007268 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2026-02-24 |
| 00875197007251 | cobas® liat CT, NG and MG control kit | Roche Molecular Systems, Inc. | 2026-02-24 |
| 30382904402960 | BD Molecular Swab Sample Buffer Tubes | BECTON, DICKINSON AND COMPANY | 2024-02-26 |
| 30382904439232 | BD Molecular LBC Sample Buffer Tubes | BECTON, DICKINSON AND COMPANY | 2024-02-23 |
| 15420045511880 | Aptima® | Hologic, Inc. | 2023-10-26 |
| 00810031720064 | Visby Medical Sexual Health Test | Visby Medical, Inc. | 2023-04-19 |
| 15420045514966 | APTIMA | Hologic, Inc. | 2022-07-28 |
| 00382904439798 | BD CTGCTV2 | BECTON, DICKINSON AND COMPANY | 2022-06-08 |
| 15420045512832 | Aptima Combo 2® | Hologic, Inc. | 2020-06-16 |
| 15420045512849 | Aptima Combo 2® | Hologic, Inc. | 2020-06-16 |
| 15420045512900 | Aptima Combo 2® | Hologic, Inc. | 2020-06-16 |
| 00382904429706 | BD MAX™ CT/GC/TV | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00875197005783 | cobas CTNG Positive Control Kit | Roche Molecular Systems, Inc. | 2018-04-26 |
| 00875197005776 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | 2018-04-26 |
| 00875197005721 | cobas® PCR Media Uni Swab Sample Kit | Roche Molecular Systems, Inc. | 2017-03-27 |
| 30382904433766 | BD MAX™ UVE Specimen Collection Kit | BECTON, DICKINSON AND COMPANY | 2016-10-17 |
| 30382904434206 | BD MAX™ UVE Sample Buffer Tubes | BECTON, DICKINSON AND COMPANY | 2016-10-17 |
| 00382904404611 | BD PT ET CT/GC Amplified DNA Assay Male Urethral Collection and Transport Kit | BECTON, DICKINSON AND COMPANY | 2016-07-13 |
| 00382902201434 | BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit | BECTON, DICKINSON AND COMPANY | 2016-07-12 |
| 00382904404765 | BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit | BECTON, DICKINSON AND COMPANY | 2016-07-12 |
| 00382902201427 | BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit | BECTON, DICKINSON AND COMPANY | 2016-07-12 |
| 25420045506272 | Aptima® | Hologic, Inc. | 2016-04-15 |
| 25420045506265 | Aptima® | Hologic, Inc. | 2016-04-15 |
| 00875197002911 | cobas® PCR Female Swab Sample Kit | Roche Molecular Systems, Inc. | 2016-03-31 |
| 00875197003307 | cobas® 4800 CT/NG Test | Roche Molecular Systems, Inc. | 2016-03-31 |
| 00875197005363 | cobas® 4800 CT/NG Test v2.0 | Roche Molecular Systems, Inc. | 2016-03-31 |
| 15420045500280 | Aptima® | Hologic, Inc. | 2014-09-17 |
| 15420045500785 | Progensa | Hologic, Inc. | 2014-09-17 |
| 15420045500297 | Aptima® | Hologic, Inc. | 2014-09-17 |