Home › Device types › GNX
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
FDA product code GNX · Class 1 · Microbiology
35
Registered devices
243
Adverse events
10
Recalls
18
510(k) clearances
Devices with this code
BD Veritor™ Plus CLIA-Waived Combo Pack — BECTON, DICKINSON AND COMPANYBD Veritor™ Plus Laboratory Combo Pack — BECTON, DICKINSON AND COMPANYOSOM Flu Dipstick 25 Test Kit — Sekisui Diagnostics, LLCN/A — Zhengzhou Shiyi Biotech Co., Ltd.BD Veritor™ System Laboratory Combo Pack — BECTON, DICKINSON AND COMPANYBioSign Flu A+B card — PRINCETON BIOMEDITECH CORPORATIONOraSure Quickflu Nasopharyngeal Wash / Aspirate — Orasure Technologies, Inc.QuickVue — QUIDEL CORPORATIONStatus Flu A+B Nasal Wash/Aspirate Kit — PRINCETON BIOMEDITECH CORPORATIONQuickVue — QUIDEL CORPORATIONMcKesson — MCKESSON MEDICAL-SURGICAL INC.Sofia — QUIDEL CORPORATIONStatus Flu A+B card — PRINCETON BIOMEDITECH CORPORATIONRemel — REMEL, INC.OSOM Influenza Control Kit — Sekisui Diagnostics, LLCStatus Flu A+B Validation Kit — PRINCETON BIOMEDITECH CORPORATIONPoly stat — POLYMEDCO, INC.Rapid Response — BTNX IncHenry Schein — HENRY SCHEIN, INC.Status Flu A+B card — PRINCETON BIOMEDITECH CORPORATIONCHORUS INFLUENZA A IgG — DIESSE DIAGNOSTICA SENESE SPAStatus Flu A & B — PRINCETON BIOMEDITECH CORPORATIONCHORUS INFLUENZA B IgG — DIESSE DIAGNOSTICA SENESE SPAQuickVue — QUIDEL CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-02-19 | Remel Inc | Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit. |
| 2012-12-03 | Quidel Corporation | Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to mis |
| 2012-03-09 | Princeton Biomeditech Corp | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
| 2012-03-09 | Princeton Biomeditech Corp | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
| 2012-03-09 | Princeton Biomeditech Corp | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
| 2008-07-02 | Inverness Medical BioStar Inc. | Diagnostic kits for flu were distributed with incorrect components. |
| 2007-03-28 | Binax, Inc. dba IMPD | Tip of the foam swab could detach from the shaft causing injury to the patient. |
| 2007-03-28 | Binax, Inc. dba IMPD | Tip of the foam swab could detach from the shaft causing injury to the patient. |
| 2007-03-28 | Binax, Inc. dba IMPD | Tip of the foam swab could detach from the shaft causing injury to the patient. |
| 2007-03-28 | Binax, Inc. dba IMPD | Tip of the foam swab could detach from the shaft causing injury to the patient. |
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