Atlas FDA

GNX

18 FDA 510(k) clearances · Product code

90 daysmedian time to decision
374 days90th percentile
18clearances measured

FDA profile

Official device name
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Device class
Class I (low risk)
Regulation
21 CFR 866.3330
Medical specialty
Microbiology
Adverse events (MAUDE)
1995: 1 · 2021: 36 · 2022: 32 · 2023: 61 · 2025: 93
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ALERE BINAXNOW INFLUENZA A & B CARD (K133411)Alere Scarborough, Inc D/B/A Binax, Inc.2013-12-05
SAS FLUALERT A & B, SAS INFLUENZA A TEST (K132352)Sa Scientific , Ltd.2013-08-22
REMEL XPECT FLU A&B (K131804)Remel, Inc.2013-07-12
QUICK VUE INFLUENZA (K131599)Quidel Corporation2013-07-05
SOFIA INFLUENZA A+B FIA (K131606)Quidel Corp.2013-07-05
QUICKVUE INFLUENZA A+B (K131619)Quidel Corp.2013-06-28
OSOM INFLUENZA A&B TEST MODEL 190 (K123182)SEKISUI Diagnostics, LLC2012-11-05
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (K971494)Zymetx, Inc.1997-09-10
BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (K924006)Baxter Healthcare Corp1992-12-29
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B (K901493)Whittaker Bioproducts, Inc.1990-06-27
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A (K893579)Whittaker Bioproducts, Inc.1990-01-16
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION (K884191)Baxter Diagnostics, Inc.1988-11-22
IMAGEN INFLUENZA VIRUS A AND B TESTMI (K872958)Boots-Celltech Diagnostics, Inc.1988-02-24
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B (K871231)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A (K871233)Microscan Div. Baxter Healthcare Corp.1987-06-26
INFLUENZA A2 VIRUS (K843659)Institute Virion , Ltd.1985-09-26
IN FLUENZA B VIRUS (K843660)Institute Virion , Ltd.1985-09-26
INFLUENZA A & B S-ANTIGEN & CONTROLS (K802931)Orion Diagnostica, Inc.1981-01-12

Track GNX automatically

Every clearance here is in the API, with alerts when new ones post.