Dna-Reagents, Neisseria
FDA product code LSL · Class II (moderate risk) · 21 CFR 866.3390 · Microbiology
45510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Gen-Probe, Inc. 15
- Becton Dickinson & Co. 8
- Roche Molecular Systems, Inc. 6
- Digene Corp. 3
- Roche Diagnostics Corp. 2
- Cepheid 2
- Hologic, Inc. 2
- Ortho Diagnostic Systems, Inc. 1
- Technology Management & Marketing, Inc. 1
- Abbott Laboratories 1
- Sierra Diagnostics 1
- Becton Dickinson Microbiology Systems 1
- Hologic / Gen-Probe Incorporated 1
- Abbott Molecular, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231329 | Aptima Neisseria gonorrhoeae AssayLSL · Traditional | Hologic, Inc. | 01/26/2024SE |
| K180681 | Aptima Combo 2 Assay (Panther System)LSL · Traditional | Hologic, Inc. | 06/13/2018SE |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systemsLSL · Traditional | Roche Molecular Systems, Inc. | 03/21/2018SE |
| K173840 | Xpert CT/NGLSL · Traditional | Cepheid | 03/16/2018SE |
| K163184 | cobas® CT/NG v2.0 TestLSL · Traditional | Roche Molecular Systems, Inc. | 02/09/2017SE |
| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | Becton, Dickinson & CO | 05/20/2014SE |
| K140354 | Abbott Multi-Collect Specimen Collection Kit, Abbott Real Time Ct/NgLSL · Traditional | Abbott Molecular, Inc. | 05/09/2014SE |
| K140887 | Cobas Ct/Ng V2.0 TestLSL · Special | Roche Molecular Systems, Inc. | 05/05/2014SE |
| K132270 | Cobas Ct/Ng V2.0 TestLSL · Traditional | Roche Molecular Systems, Inc. | 12/02/2013SE |
| K132251 | Aptima Combo 2 Assay (Panther System)LSL · Traditional | Hologic / Gen-Probe Incorporated | 10/17/2013SE |
| K121710 | Xpert Ct/NgLSL · Traditional | Cepheid | 12/27/2012SE |
| K111409 | Aptima Combo 2 AssayLSL · Traditional | Gen-Probe, Inc. | 05/03/2012SE |
| K091730 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | Becton, Dickinson & CO | 11/13/2009SE |
| K090971 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | Becton, Dickinson & CO | 06/05/2009SE |
| K090827 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | Becton, Dickinson & CO | 05/27/2009SE |
| K081825 | BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified DNA AssayLSL · Traditional | Becton, Dickinson & CO | 12/11/2008SE |
| K070172 | Amplicor Ct/Ng Test for Neisseria GonorrhoeaeLSL · Traditional | Roche Diagnostics Corporation | 04/17/2007SE |
| K063664 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae MODEL#1091LSL · Traditional | Gen-Probe, Inc. | 01/25/2007SE |
| K062440 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091LSL · Traditional | Gen-Probe, Inc. | 11/07/2006SE |
| K061509 | Tigris DTS Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1196LSL · Traditional | Gen-Probe, Inc. | 10/04/2006SE |
| K060652 | Tigris DTS Gen-Probe Aptima Combo 2 AssayLSL · Traditional | Gen-Probe, Inc. | 08/17/2006SE |
| K053289 | Cobas Amplicor Ct/Ng Test for Neisseria GonorrhoeaeLSL · Traditional | Roche Diagnostics Corp. | 08/10/2006SE |
| K052481 | BD Viper SystemLSL · Special | Becton, Dickinson & CO | 11/28/2005SE |
| K052224 | BD Probe Tec Urine Preservative TransportLSL · Special | Becton, Dickinson & CO | 09/12/2005SE |
| K043224 | Gen-Probe Aptima Combo 2 AssayLSL · Traditional | Gen-Probe, Inc. | 08/09/2005SE |
| K043144 | Gen-Probe Aptima Assay for Neisseria GonorrhoeaeLSL · Traditional | Gen-Probe, Inc. | 03/14/2005SE |
| K032554 | Gen-Probe Aptima Combo 2 AssayLSL · Traditional | Gen-Probe, Inc. | 12/31/2003SE |
| K032194 | Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test AssaysLSL · Traditional | Gen-Probe, Inc. | 12/24/2003SE |
| K010893 | Modification to Hybrid Capture 2 Gc-Id DNA Test, Model 03M92-01LSL · Traditional | Digene Corp. | 09/24/2001SE |
| K012351 | Bdprobetec Et Ct/Gc Amplified DNA AssayLSL · Traditional | Becton, Dickinson & CO | 09/18/2001SE |
| K003395 | Gen-Probe Aptima Combo 2 AssayLSL · Traditional | Gen-Probe, Inc. | 05/21/2001SE |
| K981567 | Hybrid Capture II Ct/Gc TestLSL · Traditional | Digene Corp. | 02/29/2000SE |
| K974503 | Roche Amplicor Ct/Ng Test for Neisseria GonorrhoeaeLSL · Traditional | Roche Molecular Systems, Inc. | 12/01/1999SE |
| K981485 | Hybrid Capture II Gc-IdLSL · Traditional | Digene Corp. | 11/29/1999SE |
| K984631 | Bdprobetec Et Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified DNA AssayLSL · Traditional | Becton Dickinson Microbiology Systems | 11/04/1999SE |
| K991268 | Gonostat Gonococcal Detection KitLSL · Traditional | Sierra Diagnostics | 08/11/1999SE |
| K974342 | Roche Cobas Amplicor Ct/Ng Test for Neisseria GonorrhoeaeLSL · Traditional | Roche Molecular Systems, Inc. | 05/28/1999SE |
| K935833 | LCX Neisseria Gonorrhoeae AssayLSL · Traditional | Abbott Laboratories | 05/06/1996SE |
| K940979 | Gen-Probe Pace 2C Syst Chlamydia Trac/Neisser GonorrLSL · Traditional | Gen-Probe, Inc. | 10/31/1994SE |
| K920301 | Pace 2 Neisseria Gonorrhoeae Probe Confirm. AssayLSL · Traditional | Gen-Probe, Inc. | 04/26/1994SE |
| K895583 | Accuprobe Neisseria Gonorrhoeae Culture Confirma.LSL · Traditional | Gen-Probe, Inc. | 11/14/1989SE |
| K883486 | GonostatLSL · Traditional | Technology Management & Marketing, Inc. | 08/15/1989SE |
| K881277 | Pace System for Neisseria Gonorrhoeae Addi. ClaimsLSL · Traditional | Gen-Probe, Inc. | 04/25/1988SE |
| K874620 | Gen-Probe Pace System for Neisseria GonorrhoeaeLSL · Traditional | Gen-Probe, Inc. | 03/01/1988SE |
| K872628 | Gonospot* DNA Probe Culture Confirmation TestLSL · Traditional | Ortho Diagnostic Systems, Inc. | 12/21/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0592-2018 Class II | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075…Cepheid has received reports that some of our customers have experienced a higher number of temperature… | Cepheid | 10/09/2017Terminated |
| Z-2432-2015 Class III | Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology:…Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with… | Cepheid | 07/27/2015Terminated |
| Z-2431-2015 Class III | Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50…Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with… | Cepheid | 07/27/2015Terminated |