Panels › Microbiology › Product code PQA · Class 2
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Regulation 866.3975
2510(k)s in 12 months (13 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in PQA
| Company | 510(k)s | Recalls |
|---|---|---|
| Becton Dickinson & Co. | 0 | 3 |
| Cepheid | 3 | 0 |
| Hologic, Inc. | 3 | 0 |
| Becton, Dickinson and Company | 2 | 0 |
| Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2 | 0 |
| Biofire Diagnostics, LLC | 1 | 0 |
| Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 1 | 0 |
| Roche Molecular Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2026 | K262136 | BIOFIRE SPOTFIRE Vaginitis (VG) Panel Biofire Diagnostics, LLC | PQA |
| Jul 16, 2026 | K260021 | cobas® BV/CV Roche Molecular Systems, Inc. | PQA |
| Dec 19, 2024 | K243725 | BD Vaginal Panel Becton, Dickinson and Company | PQA |
| Nov 25, 2024 | K243345 | Aptima BV Assay; Aptima CV/TV Assay Hologic, Inc. | PQA |
| Oct 19, 2023 | K231381 | Xpert Xpress MVP; GeneXpert Xpress System Cepheid | PQA |
| Mar 6, 2023 | K223653 | BD Vaginal Panel Becton, Dickinson and Company | PQA |
| Jun 7, 2022 | K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System Cepheid | PQA |
| Feb 9, 2022 | K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System Cepheid | PQA |
| Oct 18, 2021 | K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit Geneohm Sciences Canada, Inc. (Bd Life Sciences), CA | PQA |
| Oct 21, 2019 | K191957 | BD MAX Vaginal Panel Geneohm Sciences Canada, Inc. (Bd Diagnostics), CA | PQA |
| May 23, 2019 | K190452 | Aptima BV Assay Hologic, Inc. | PQA |
| May 16, 2019 | K190472 | Aptima CV/TV Assay Hologic, Inc. | PQA |
| Oct 28, 2016 | DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument Geneohm Sciences Canada, Inc. (Bd Diagnostics), CA | PQA |
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