FDA Product Code
FDA Product Code QEP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3393
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems | Roche Molecular Systems, Inc. | 2026-07-08 | Traditional | PDF ↗ |
| K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2026-05-15 | Dual Track | PDF ↗ |
| K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | 2026-05-15 | Dual Track | PDF ↗ |
| K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | 2025-10-01 | Dual Track | PDF ↗ |
| K243343 | BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, | 2025-04-22 | Traditional | PDF ↗ |
| K240217 | cobas® liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | 2025-01-17 | Dual Track | PDF ↗ |
| K240197 | cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2025-01-16 | Dual Track | PDF ↗ |
| K230267 | NeuMoDx CT/NG Assay 2.0 | Neumodx Molecular, Inc. | 2023-12-22 | Traditional | PDF ↗ |
| K220407 | Visby Medical Sexual Health Test | Visby Medical | 2023-03-07 | Dual Track | PDF ↗ |
| K222379 | Alinity m STI Assay | Abbott Molecular, Inc. | 2023-03-03 | Traditional | PDF ↗ |
| K220321 | 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 | Hologic, Inc. | 2022-06-03 | Special | PDF ↗ |
| K210585 | BD CTGCTV2 | Becton, Dickinson and Company | 2022-05-10 | Traditional | PDF ↗ |
| K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022-04-29 | Traditional | PDF ↗ |
| K193081 | Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit | Rheonix, Inc. | 2021-12-17 | Traditional | PDF ↗ |
| K200748 | Visby Medical Sexual Health | Visby Medical | 2021-08-26 | Dual Track | PDF ↗ |
| K202408 | cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2021-01-21 | Traditional | PDF ↗ |
| K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | Hologic, Inc. | 2020-05-17 | Special | PDF ↗ |
| K200533 | binx io CT/NG Assay and binx io CT/NG System | Binx Health, Inc. | 2020-04-27 | Traditional | PDF ↗ |
| K200436 | 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 | Hologic, Inc. | 2020-03-23 | Special | PDF ↗ |
| K191352 | binx health io CT/NG Assay | Binx Health, Inc. | 2019-08-08 | Traditional | PDF ↗ |
| K190515 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | 2019-05-23 | Traditional | PDF ↗ |
| K190441 | 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 | Cepheid | 2019-05-23 | Traditional | PDF ↗ |
| K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | 2019-05-22 | Traditional | PDF ↗ |
| DEN180047 | Aptima Mycoplasma genitalium Assay | Hologic, Inc. | 2019-01-23 | Direct | — |
Product code QEP · Class II · Microbiology. Data: openFDA.