Product code MKZ
- Device name
- Dna Probe, Nucleic Acid Amplification, Chlamydia
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3120
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230451 | Aptima® Chlamydia trachomatis Assay | Hologic, Inc. | 2023-11-16 |
| K140446 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2014-05-20 |
| K110923 | COBAS 4800 CT / NG TEST | Roche Molecular Systems, Inc. | 2012-01-24 |
| K091724 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2009-11-13 |
| K090824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2009-06-02 |
| K081824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2008-12-11 |
| K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT | Abbott Molecular, Inc. | 2008-07-10 |
| K070174 | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY | Roche Diagnostics Corporation | 2007-04-16 |
| K063451 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 | Gen-Probe, Inc. | 2007-01-22 |
| K061413 | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM | Gen-Probe, Inc. | 2006-10-13 |
| K053287 | COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Diagnostics Corp. | 2006-08-10 |
| K053446 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 | Gen-Probe, Inc. | 2006-07-25 |
| K043072 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS | Gen-Probe, Inc. | 2005-01-27 |
| K973707 | ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Molecular Systems, Inc. | 1999-08-04 |
| K973718 | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Molecular Systems, Inc. | 1998-12-15 |
| K964507 | ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST | Roche Molecular Systems, Inc. | 1997-06-13 |
| K962217 | GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT | Gen-Probe, Inc. | 1996-11-27 |
| K934622 | LCX CHLAMYDIA TRACHOMATIS ASSAY | Abbott Laboratories | 1995-12-08 |
| K922906 | AMPLICOR CHLAMYDIA TRACHOMATIS TEST | Roche Molecular Systems, Inc. | 1993-06-15 |
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| 30382904439232 | BD Molecular LBC Sample Buffer Tubes | BECTON, DICKINSON AND COMPANY | 2024-02-23 |
| 00810031720071 | Visby Medical Power Adapter, Right Angle | Visby Medical, Inc. | 2023-04-19 |
| 00810031720064 | Visby Medical Sexual Health Test | Visby Medical, Inc. | 2023-04-19 |
| 15420045514966 | APTIMA | Hologic, Inc. | 2022-07-28 |
| 15420045514973 | APTIMA | Hologic, Inc. | 2022-07-28 |
| 00382904439040 | BD CTGCTV2 for BD MAX™ System | BECTON, DICKINSON AND COMPANY | 2022-07-14 |
| 00382904439897 | BD COR™ MX | BECTON, DICKINSON AND COMPANY | 2022-06-16 |
| 00810031720057 | Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack | Visby Medical, Inc. | 2021-09-15 |
| 00810031720033 | Visby Medical Power Adapter | Visby Medical, Inc. | 2021-09-15 |
| 00810031720002 | Visby Medical Sexual Health Click Test | Visby Medical, Inc. | 2021-09-15 |
| 15420045512832 | Aptima Combo 2® | Hologic, Inc. | 2020-06-16 |
| 15420045512894 | Aptima Combo 2® | Hologic, Inc. | 2020-06-16 |
| 00382904429706 | BD MAX™ CT/GC/TV | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382904434206 | BD MAX™ UVE Sample Buffer Tubes | BECTON, DICKINSON AND COMPANY | 2016-10-17 |
| 30382904433766 | BD MAX™ UVE Specimen Collection Kit | BECTON, DICKINSON AND COMPANY | 2016-10-17 |
| 30382904414444 | Dilution Tubes (LBC) for the BD ProbeTec™ Qx Amplified DNA Assays | BECTON, DICKINSON AND COMPANY | 2016-07-08 |
| 25420045506272 | Aptima® | Hologic, Inc. | 2016-04-15 |
| 25420045506265 | Aptima® | Hologic, Inc. | 2016-04-15 |
| 15420045506237 | Aptima® | Hologic, Inc. | 2016-04-15 |
| 15420045505735 | Aptima Combo 2® | Hologic, Inc. | 2016-04-11 |
| 15420045505728 | Aptima Combo 2® | Hologic, Inc. | 2016-04-11 |
| 15420045505711 | Aptima Combo 2® | Hologic, Inc. | 2016-04-11 |
| 15420045505704 | Aptima Combo 2® | Hologic, Inc. | 2016-04-11 |
| 15420045500242 | Aptima® | Hologic, Inc. | 2014-09-17 |
| 15420045500297 | Aptima® | Hologic, Inc. | 2014-09-17 |
| 15420045500273 | Aptima® | Hologic, Inc. | 2014-09-17 |
| 15420045500266 | Aptima® | Hologic, Inc. | 2014-09-17 |
| 15420045500259 | Aptima® | Hologic, Inc. | 2014-09-17 |