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Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
FDA product code QEP · Class 2 · Microbiology
37
Registered devices
39
Adverse events
4
Recalls
24
510(k) clearances
Devices with this code
Visby Medical Men’s Sexual Health Test — Visby Medical, Inc.cobas® TV/MG — Roche Molecular Systems, Inc.Aptima Combo 2® — Hologic, Inc.Aptima® — HOLOGIC LTD.cobas® TV/MG Positive Control Kit — Roche Molecular Systems, Inc.Aptima Combo 2® — Hologic, Inc.Alinity m — ABBOTT MOLECULAR INC.Xpert CT/NG — CEPHEIDBD CTGCTV2 — BECTON, DICKINSON AND COMPANYAPTIMA — Hologic, Inc.Alinity m — ABBOTT MOLECULAR INC.APTIMA — Hologic, Inc.binx io — BINX HEALTH LIMITEDAptima Combo 2® — Hologic, Inc.APTIMA — Hologic, Inc.Xpert CT/NG — CEPHEIDAPTIMA — Hologic, Inc.cobas® TV/MG Positive Control Kit — Roche Molecular Systems, Inc.Xpert Urine Specimen Collection Kit — CEPHEIDAlinity m — ABBOTT MOLECULAR INC.BD COR™ MX — BECTON, DICKINSON AND COMPANYAPTIMA — Hologic, Inc.Alinity m — ABBOTT MOLECULAR INC.Aptima® — HOLOGIC LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti |
| 2024-09-12 | Abbott Molecular, Inc. | Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and A |
| 2023-03-29 | Binx Health, Inc. | May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce eit |
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