Panels › Microbiology › Product code PQA · Class 2
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Regulation 866.3975
1510(k)s in 12 months (12 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 |
| Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 1 | 0 |
| Roche Molecular Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max Vaginal Panel;
Catalog # 443712 Terminated |
PQA | None listed |
| Sep 24, 2018 | Becton Dickinson & Co. BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated Terminated |
PQA | None listed |
| Sep 24, 2018 | Becton Dickinson & Co. BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and Terminated |
PQA | None listed |
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