FDA 510(k) Applications for Medical Device Product Code "QEP"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K222379 | Abbott Molecular Inc. | Alinity m STI Assay | 03/03/2023 |
| K202977 | Abbott Molecular, Inc. | Alinity m STI Assay | 04/29/2022 |
| K243343 | BD Integrated Diagnostic Solutions/Becton, | BD CTGCTV2 | 04/22/2025 |
| K210585 | Becton Dickinson and Company | BD CTGCTV2 | 05/10/2022 |
| K200533 | binx health Inc | binx io CT/NG Assay and binx io CT/NG System | 04/27/2020 |
| K191352 | binx health, Inc. | binx health io CT/NG Assay | 08/08/2019 |
| K190441 | Cepheid | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit | 05/23/2019 |
| K220321 | Hologic, Inc. | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris | 06/03/2022 |
| K190515 | Hologic, Inc. | Aptima Combo 2 Assay (Panther System) | 05/23/2019 |
| K200866 | Hologic, Inc. | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | 05/17/2020 |
| K200436 | Hologic, Inc. | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit | 03/23/2020 |
| DEN180047 | Hologic, Inc. | Aptima Mycoplasma genitalium Assay | 01/23/2019 |
| K230267 | NeuMoDx Molecular, Inc. | NeuMoDx CT/NG Assay 2.0 | 12/22/2023 |
| K193081 | Rheonix, Inc | Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit | 12/17/2021 |
| K202408 | Roche Molecular Systems, Inc. | cobas CTNG for use on cobas 6800/8800 systems | 01/21/2021 |
| K190433 | Roche Molecular Systems, Inc. | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit | 05/22/2019 |
| K240217 | Roche Molecular Systems, Inc. | cobas« liat CT/NG nucleic acid test | 01/17/2025 |
| K240197 | Roche Molecular Systems, Inc. | cobas« liat CT/NG/MG nucleic acid test | 01/16/2025 |
| K200748 | Visby Medical | Visby Medical Sexual Health | 08/26/2021 |
| K220407 | Visby Medical | Visby Medical Sexual Health Test | 03/07/2023 |
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