Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3330](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3330) → GNX — Antigens, Cf (Including Cf Control), Influenza Virus A, B, C # GNX · Antigens, Cf (Including Cf Control), Influenza Virus A, B, C _Microbiology · 21 CFR 866.3330 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX ## Overview - **Product Code:** GNX - **Device Name:** Antigens, Cf (Including Cf Control), Influenza Virus A, B, C - **Regulation:** [21 CFR 866.3330](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3330) - **Device Class:** 1 - **Review Panel:** [Microbiology](/submissions/MI) ## Identification Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. ## Recent Cleared Devices (18 of 18) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K133411](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K133411.md) | ALERE BINAXNOW INFLUENZA A & B CARD | Alere Scarborough, Inc D/B/A Binax, Inc. | Dec 5, 2013 | SESE | | [K132352](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K132352.md) | SAS FLUALERT A & B, SAS INFLUENZA A TEST | Sa Scientific , Ltd. | Aug 22, 2013 | SESE | | [K131804](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K131804.md) | REMEL XPECT FLU A&B | Remel, Inc. | Jul 12, 2013 | SESE | | [K131606](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K131606.md) | SOFIA INFLUENZA A+B FIA | Quidel Corp. | Jul 5, 2013 | SESE | | [K131599](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K131599.md) | QUICK VUE INFLUENZA | Quidel Corporation | Jul 5, 2013 | SESE | | [K131619](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K131619.md) | QUICKVUE INFLUENZA A+B | Quidel Corp. | Jun 28, 2013 | SESE | | [K123182](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K123182.md) | OSOM INFLUENZA A&B TEST MODEL 190 | SEKISUI Diagnostics, LLC | Nov 5, 2012 | SESE | | [K971494](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K971494.md) | VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES | Zymetx, Inc. | Sep 10, 1997 | SESE | | [K924006](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K924006.md) | BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY | Baxter Healthcare Corp | Dec 29, 1992 | SESE | | [K901493](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K901493.md) | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B | Whittaker Bioproducts, Inc. | Jun 27, 1990 | SESE | | [K893579](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K893579.md) | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A | Whittaker Bioproducts, Inc. | Jan 16, 1990 | SESE | | [K884191](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K884191.md) | INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION | Baxter Diagnostics, Inc. | Nov 22, 1988 | SESE | | [K872958](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K872958.md) | IMAGEN INFLUENZA VIRUS A AND B TESTMI | Boots-Celltech Diagnostics, Inc. | Feb 24, 1988 | SESE | | [K871233](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K871233.md) | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A | Microscan Div. Baxter Healthcare Corp. | Jun 26, 1987 | SESE | | [K871231](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K871231.md) | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B | Microscan Div. Baxter Healthcare Corp. | Jun 26, 1987 | SESE | | [K843660](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K843660.md) | IN FLUENZA B VIRUS | Institute Virion , Ltd. | Sep 26, 1985 | SESE | | [K843659](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K843659.md) | INFLUENZA A2 VIRUS | Institute Virion , Ltd. | Sep 26, 1985 | SESE | | [K802931](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX/K802931.md) | INFLUENZA A & B S-ANTIGEN & CONTROLS | Orion Diagnostica, Inc. | Jan 12, 1981 | SESE | ## Top Applicants - Institute Virion , Ltd. — 2 clearances - Microscan Div. Baxter Healthcare Corp. — 2 clearances - Quidel Corp. — 2 clearances - Whittaker Bioproducts, Inc. — 2 clearances - Alere Scarborough, Inc D/B/A Binax, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com