PQA
12 FDA 510(k) clearances · Product code
90 daysmedian time to decision
291 days90th percentile
12clearances measured
FDA profile
- Official device name
- Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3975
- Medical specialty
- Microbiology
- FDA definition
- A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.
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| Record | Firm | Date |
|---|---|---|
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
| BD Vaginal Panel (K243725) | Becton, Dickinson and Company | 2024-12-19 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Xpert Xpress MVP; GeneXpert Xpress System (K231381) | Cepheid | 2023-10-19 |
| BD Vaginal Panel (K223653) | Becton, Dickinson and Company | 2023-03-06 |
| Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K221160) | Cepheid | 2022-06-07 |
| Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K212213) | Cepheid | 2022-02-09 |
| BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit (K201017) | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021-10-18 |
| BD MAX Vaginal Panel (K191957) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019-10-21 |
| Aptima BV Assay (K190452) | Hologic, Inc. | 2019-05-23 |
| Aptima CV/TV Assay (K190472) | Hologic, Inc. | 2019-05-16 |
| BD MAX Vaginal Panel, BD MAX Instrument (DEN160001) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016-10-28 |
Track PQA automatically
Every clearance here is in the API, with alerts when new ones post.