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Gull Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
57

What Gull Laboratories, Inc. makes

Gull Laboratories, Inc. manufactures in vitro diagnostic tests for detecting specific antibodies and antigens, including ELISA-based assays for CMV, toxoplasmosis, rubella, respiratory syncytial virus, herpes simplex virus (HSV), Chagas disease, varicella-zoster virus (VZV), Lyme disease, and Epstein-Barr virus (EBV). The company also produces the DetectaDot System 2000, a rapid lateral flow test for toxoplasmosis and CMV IgG.

These devices are regulated under the FDA’s 510(k) pathway, with most classified as Class I or Class II in vitro diagnostic devices. The company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue57

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  • Hsv-2 Igg Elisa Test Ref K910952

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ebv Lgg Elisa Test Ref K941198

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Toxo Test Ref K772243

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hsv-1 Igg Elisa Test Ref K910954

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Detectadot System 2000 Heterophile Test Ref K895891

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rubella Igg Elisa Test Ref K915893

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Toxo Igg Elisa Test (Modified) Ref K915891

    Active Regimes: 510(k) Registry: 510(k) Class:II

Showing 51-57 of 57