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Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
FDA product code PQA · Class 2 · Microbiology
17
Registered devices
26
Adverse events
3
Recalls
12
510(k) clearances
Devices with this code
Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Xpert® — CEPHEIDAptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.BD MAX™ Vaginal Panel — BECTON, DICKINSON AND COMPANYAptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Xpert® — CEPHEIDAptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.BD Vaginal Panel on BD COR System — BECTON, DICKINSON AND COMPANYBD Molecular Swab Collection Kit — BECTON, DICKINSON AND COMPANY
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-07-17 | Becton Dickinson & Co. | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| 2018-09-24 | Becton Dickinson & Co. | A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of |
| 2018-09-24 | Becton Dickinson & Co. | A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of |
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