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
QuickVue — QUIDEL CORPORATIONN/A — Zhengzhou Shiyi Biotech Co., Ltd.Henry Schein — HENRY SCHEIN, INC.Sofia — QUIDEL CORPORATIONQuickVue — QUIDEL CORPORATIONStatus Flu A+B Validation Kit — PRINCETON BIOMEDITECH CORPORATIONOraSure Quickflu Nasopharyngeal Wash / Aspirate — Orasure Technologies, Inc.IMAGEN Influenza Virus A and B — OXOID LIMITEDBD Veritor™ System Laboratory Combo Pack — BECTON, DICKINSON AND COMPANYQuickVue — QUIDEL CORPORATIONOraSure Quick Flu 22-Count Flu A + B Kit — Orasure Technologies, Inc.CHORUS INFLUENZA B IgG — DIESSE DIAGNOSTICA SENESE SPAOSOM Ultra Flu A&B Controls 5 Test — SEKISUI DIAGNOSTICS, LLCLongeviti Convenience Kit 5.0 — LONGEVITI NEURO SOLUTIONS LLCOSOM Influenza Control Kit — SEKISUI DIAGNOSTICS, LLCStatus Flu A & B — PRINCETON BIOMEDITECH CORPORATIONN/A — Zhengzhou Shiyi Biotech Co., Ltd.BioSign Flu A+B card — PRINCETON BIOMEDITECH CORPORATIONStatus Flu A+B Nasal Wash/Aspirate Kit — PRINCETON BIOMEDITECH CORPORATIONSofia — QUIDEL CORPORATIONStatus Flu A+B card — PRINCETON BIOMEDITECH CORPORATIONPoly stat — POLYMEDCO, INC.BioSign Flu A+B card — PRINCETON BIOMEDITECH CORPORATIONBioSign Flu A+B card — PRINCETON BIOMEDITECH 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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