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Devices Detecting Influenza A, B, And C Virus Antigens
FDA product code PSZ · Class 2 · Microbiology
31
Registered devices
169
Adverse events
5
Recalls
72
510(k) clearances
Devices with this code
OSOM Ultra Flu Aspirate 25T Kit — SEKISUI DIAGNOSTICS, LLCINNOVITA — Innovita (Tangshan) Biological Technology Co., Ltd.BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit — BECTON, DICKINSON AND COMPANYAcucy Reader A/C Adapter — SEKISUI DIAGNOSTICS, LLCStatus™ COVID-19/Flu — PRINCETON BIOMEDITECH CORPORATIONBD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit — BECTON, DICKINSON AND COMPANYAlere Influenza A & B Control Swab Kit — Alere Scarborough, Inc.Acucy System — SEKISUI DIAGNOSTICS, LLCOSOM ULTRA PLUS FLU A&B Test — SEKISUI DIAGNOSTICS, LLCViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test — Lumos Diagnostics, Inc.BinaxNOW Influenza A & B Card 2 Control Swab Kit — Alere Scarborough, Inc.ID NOW Influenza A & B 2 — Alere Scarborough, Inc.Acucy System Universal Drawer — SEKISUI DIAGNOSTICS, LLCBinaxNOW Influenza A & B Card 2 — Alere Scarborough, Inc.ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate Kit — MERIDIAN BIOSCIENCE, INC.Alere BinaxNOW Influenza A & B Card 2 — Alere Scarborough, Inc.ID NOW Influenza A & B Control Swab Kit — Alere Scarborough, Inc.Acucy Influenza A&B Control Kit — SEKISUI DIAGNOSTICS, LLCCARDINAL HEALTH — Cardinal Health 200, LLCFluoro-CheckTM Influenza A+B — NANO-DITECH CORPORATIONAlere BinaxNOW Influenza A & B Card 2 Control Swab Kit — Alere Scarborough, Inc.OSOM ULTRA PLUS FLU A&B Control Kit — SEKISUI DIAGNOSTICS, LLCNano-Check Influenza+COVID-19 Dual Test — NANO-DITECH CORPORATIONOSOM Ultra Flu A&B 25T Kit — SEKISUI DIAGNOSTICS, LLC
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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