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Trichomonas Vaginalis Nucleic Acid Amplification Test System
FDA product code OUY · Class 2 · Immunology
44
Registered devices
30
Adverse events
4
Recalls
10
510(k) clearances
Devices with this code
Aptima® — Hologic, Inc.Control Set for the BD ProbeTec™ CT/GC/TV Qx Amplified DNA Assays — BECTON, DICKINSON AND COMPANYBD Molecular Urine Transport Kit — BECTON, DICKINSON AND COMPANYAptima® — Hologic, Inc.Control Set for the BD ProbeTec™ Trichomonas vaginalis — BECTON, DICKINSON AND COMPANYBD MAX™ CT/GC/TV — Geneohm Sciences Canada IncVisby Medical Power Adapter — Visby Medical, Inc.Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack — Visby Medical, Inc.Alinity m — ABBOTT MOLECULAR INC.Aptima® — Hologic, Inc.BD ProbeTec™ Trichomonas vaginalis — BECTON, DICKINSON AND COMPANYBD CTGCTV2 — BECTON, DICKINSON AND COMPANYBD CTGCTV2 for BD MAX™ System — BECTON, DICKINSON AND COMPANYAPTIMA — Hologic, Inc.Alinity m — ABBOTT MOLECULAR INC.APTIMA — Hologic, Inc.BD MAX™ UVE Sample Buffer Tubes — BECTON, DICKINSON AND COMPANYBD MAX™ Vaginal Panel — BECTON, DICKINSON AND COMPANYAptima® — Hologic, Inc.Visby Medical Sexual Health Click Test — Visby Medical, Inc.Visby Medical Power Adapter, Right Angle — Visby Medical, Inc.BD Molecular LBC Sample Buffer Tubes — BECTON, DICKINSON AND COMPANYAptima® — Hologic, Inc.Xpert Urine Specimen Collection Kit — CEPHEID
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2019-07-17 | Becton Dickinson & Co. | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
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