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Devices Detecting Influenza A, B, And C Virus Antigens
FDA product code PSZ · Class 2 · Microbiology
31
Registered devices
172
Adverse events
5
Recalls
73
510(k) clearances
Devices with this code
Nano-Check Influenza+COVID-19 Dual Test — NANO-DITECH CORPORATIONOSOM Ultra Flu Aspirate 25T Kit — Sekisui Diagnostics, LLCViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test — Lumos Diagnostics, Inc.BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit — BECTON, DICKINSON AND COMPANYBD Veritor™ System CLIA-Waived Combo Pack — BECTON, DICKINSON AND COMPANYAlere BinaxNOW Influenza A & B Card 2 — Alere Scarborough, Inc.Acucy System — Sekisui Diagnostics, LLCBinaxNOW Influenza A & B Card 2 — Alere Scarborough, Inc.BinaxNOW Influenza A & B Card 2 Control Swab Kit — Alere Scarborough, Inc.Fluoro-CheckTM Influenza A+B — NANO-DITECH CORPORATIONAlere Influenza A & B Control Swab Kit — Alere Scarborough, Inc.Alere Influenza A & B Test — Alere Scarborough, Inc.Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit — Alere Scarborough, Inc.OSOM Ultra Flu A&B 25T Kit — Sekisui Diagnostics, LLCID NOW Influenza A & B 2 — Alere Scarborough, Inc.Acucy Flu Test Kit — Sekisui Diagnostics, LLCAimStep Flu A&B Test Kit — GERMAINE LABORATORIES, INCBD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit — BECTON, DICKINSON AND COMPANYINNOVITA — Innovita (Tangshan) Biological Technology Co., Ltd.ImmunoCard STAT! FLU A&B — MERIDIAN BIOSCIENCE, INC.Remel — REMEL, INC.ID NOW Influenza A & B Control Swab Kit — Alere Scarborough, Inc.Acucy Printer Paper — Sekisui Diagnostics, LLCImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate Kit — MERIDIAN BIOSCIENCE, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-05 | Becton Dickinson & Co. | May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is |
| 2020-09-25 | Quidel Corporation | Due to false positive results. |
| 2019-04-03 | Becton Dickinson & Co. | Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead |
| 2019-04-03 | Becton Dickinson & Co. | Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead |
| 2017-12-15 | Quidel Corporation | The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first p |
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