Panels › Microbiology › Product code QEP · Class 2
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Regulation 866.3393
3510(k)s in 12 months (24 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in QEP
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Molecular Systems, Inc. | 7 | 0 |
| Hologic, Inc. | 5 | 0 |
| Abbott Molecular, Inc. | 2 | 1 |
| Binx Health, Inc. | 2 | 1 |
| Visby Medical | 3 | 0 |
| Becton Dickinson & Co. | 0 | 2 |
| Bd Integrated Diagnostic Solutions/Becton, | 1 | 0 |
| Becton, Dickinson and Company | 1 | 0 |
| Cepheid | 1 | 0 |
| Neumodx Molecular, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2026 | 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. | QEP |
| May 15, 2026 | K253759 | cobas liat CT/NG/MG nucleic acid test Roche Molecular Systems, Inc. | QEP |
| May 15, 2026 | K253756 | cobas liat CT/NG nucleic acid test Roche Molecular Systems, Inc. | QEP |
| Oct 1, 2025 | K251501 | Visby Medical Men's Sexual Health Test Visby Medical, Inc. | QEP |
| Apr 22, 2025 | K243343 | BD CTGCTV2 Bd Integrated Diagnostic Solutions/Becton, | QEP |
| Jan 17, 2025 | K240217 | cobas® liat CT/NG nucleic acid test Roche Molecular Systems, Inc. | QEP |
| Jan 16, 2025 | K240197 | cobas® liat CT/NG/MG nucleic acid test Roche Molecular Systems, Inc. | QEP |
| Dec 22, 2023 | K230267 | NeuMoDx CT/NG Assay 2.0 Neumodx Molecular, Inc. | QEP |
| Mar 7, 2023 | K220407 | Visby Medical Sexual Health Test Visby Medical | QEP |
| Mar 3, 2023 | K222379 | Alinity m STI Assay Abbott Molecular, Inc. | QEP |
| Jun 3, 2022 | K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis As Hologic, Inc. | QEP |
| May 10, 2022 | K210585 | BD CTGCTV2 Becton, Dickinson and Company | QEP |
| Apr 29, 2022 | K202977 | Alinity m STI Assay Abbott Molecular, Inc. | QEP |
| Dec 17, 2021 | K193081 | Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Rheonix, Inc. | QEP |
| Aug 26, 2021 | K200748 | Visby Medical Sexual Health Visby Medical | QEP |
| Jan 21, 2021 | K202408 | cobas CTNG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc. | QEP |
| May 17, 2020 | K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) Hologic, Inc. | QEP |
| Apr 27, 2020 | K200533 | binx io CT/NG Assay and binx io CT/NG System Binx Health, Inc. | QEP |
| Mar 23, 2020 | K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginali Hologic, Inc. | QEP |
| Aug 8, 2019 | K191352 | binx health io CT/NG Assay Binx Health, Inc. | QEP |
| May 23, 2019 | K190515 | Aptima Combo 2 Assay (Panther System) Hologic, Inc. | QEP |
| May 23, 2019 | K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System Cepheid | QEP |
| May 22, 2019 | 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. | QEP |
| Jan 23, 2019 | DEN180047 | Aptima Mycoplasma genitalium Assay Hologic, Inc. | QEP |
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