Skip to content

Gull Laboratories, Inc.

United StatesFDA 510(k) 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

Newest first, rows 1-50 of 57

Search and filter all 57 devices
Skip device list

  • Cmv Igm Elisa Test Ref K903807

    Class II
    Active 510(k) 510(k) II

  • Detectadot System 2000 Toxo Igg Test Ref K875109

    Class II
    Active 510(k) 510(k) II

  • Rubella Igg Elisa Test Ref K941624

    Class II
    Active 510(k) 510(k) II

  • Anti-Respiratory Syncytial Virus Antibody Test Ref K882687

    Class I
    Active 510(k) 510(k) I

  • Hsv 1+2 Igg Elisa Test Ref K983541

    Class II
    Active 510(k) 510(k) II

  • Chagas' Igg Elisa Test Ref K911233

    Class I
    Active 510(k) 510(k) I

  • Vzv Igg Elisa Test Ref K941046

    Class II
    Active 510(k) 510(k) II

  • Vzv Test Ref K875358

    Class II
    Active 510(k) 510(k) II

  • Cmv Igg Elisa Test Ref K915892

    Class II
    Active 510(k) 510(k) II

  • Detectadot System 2000 Cmv Igg Test Ref K875159

    Class II
    Active 510(k) 510(k) II

  • Lyme Igm Elisa Test Ref K903013

    Class II
    Active 510(k) 510(k) II

  • Ebv Igm Elisa Test Ref K910042

    Class I
    Active 510(k) 510(k) I

  • Vzv Igm Test Ref K911301

    Class II
    Active 510(k) 510(k) II

  • Influenza Mab Test/Influenza B Test Ref K913214

    Class I
    Active 510(k) 510(k) I

  • Ebna Igg Elisa Test Ref K935730

    Class I
    Active 510(k) 510(k) I

  • Hsv Test Ref K771063

    Class II
    Active 510(k) 510(k) II

  • Toxo Igm Elisa Test Ref K903324

    Class II
    Active 510(k) 510(k) II

  • Cmv Test Ref K853137

    Class II
    Active 510(k) 510(k) II

  • Influenza Mab Test/Influenza A Test Ref K913351

    Class I
    Active 510(k) 510(k) I

  • Cmv Igm Test Ref K831711

    Class II
    Active 510(k) 510(k) II

  • Gull Elisaware Ref K912558

    Class I
    Active 510(k) 510(k) I

  • Detectadot Tm System 2000 Cmv Igm Test Ref K893230

    Class II
    Active 510(k) 510(k) II

  • Ebv-Ea Test Ref K872617

    Class I
    Active 510(k) 510(k) I

  • Rubeola Test Ref K884004

    Class I
    Active 510(k) 510(k) I

  • Mumps Igg Elisa Testy Ref K971857

    Class I
    Active 510(k) 510(k) I

  • Hsv-1 Igm Elisa Test Ref K910955

    Class II
    Active 510(k) 510(k) II

  • Protectoral Ultrasonic Handpiece Processor Ref K932333

    Class I
    Active 510(k) 510(k) I

  • Ebv Test Ref K771062

    Class I
    Active 510(k) 510(k) I

  • Rubella Igm Elisa Test Ref K904084

    Class II
    Active 510(k) 510(k) II

  • Detectadot(Tm) System 2000 Rubella Igg Test Ref K892202

    Class II
    Active 510(k) 510(k) II

  • Hsv-1 Igm Elisa Test -- Modification Ref K922758

    Class II
    Active 510(k) 510(k) II

  • Toxo Igm Test Ref K880007

    Class II
    Active 510(k) 510(k) II

  • Cmv Igg Elisa Test Ref K900796

    Class II
    Active 510(k) 510(k) II

  • Toxo Igg Elisa Test Ref K962343

    Class II
    Active 510(k) 510(k) II

  • Rubeola Igg Elisa Test Ref K904854

    Class I
    Active 510(k) 510(k) I

  • Hsv Igm Test Ref K830865

    Class II
    Active 510(k) 510(k) II

  • Ebv Igm Test Ref K822734

    Class I
    Active 510(k) 510(k) I

  • Detectadot (Tm) System 2000 Toxo Igm Test Ref K893200

    Class II
    Active 510(k) 510(k) II

  • Gullsorb Igg Inactivation Reagent Ref K875254

    Class II
    Active 510(k) 510(k) II

  • Ebv-Ea(D) Igg Elisa Test Ref K940093

    Class I
    Active 510(k) 510(k) I

  • Rubella Igg Elisa Test Ref K901635

    Class II
    Active 510(k) 510(k) II

  • Rubeola Igm Elisa Test Ref K904083

    Class I
    Active 510(k) 510(k) I

  • Toxo Igg Elisa Test Ref K900354

    Class II
    Active 510(k) 510(k) II

  • Cmv-Ea Mab Test Ref K912592

    Class II
    Active 510(k) 510(k) II

  • Rsv-Mab Test Ref K912842

    Class I
    Active 510(k) 510(k) I

  • Ebv Igg Elisa Test Ref K910872

    Class I
    Active 510(k) 510(k) I

  • Hsv-2 Igm Elisa Test Ref K910953

    Class II
    Active 510(k) 510(k) II

  • Ana Test Ref K771064

    Class II
    Active 510(k) 510(k) II

  • Hsv-2 Igm Elisa Test--Modification Ref K922759

    Class II
    Active 510(k) 510(k) II

  • Ebv-Na Test Ref K880043

    Class I
    Active 510(k) 510(k) I

Rows 1-50 of 57

Showing 1-50 of 57

Frequently asked questions

How many devices does Gull Laboratories, Inc. have in the registry?

The registry currently lists 57 devices for Gull Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gull Laboratories, Inc.'s devices?

Among its 50 most recently registered devices, Gull Laboratories, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Gull Laboratories, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Gull Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Gull Laboratories, Inc. in the registry?

The most recently registered devices listed for Gull Laboratories, Inc. include CMV IGM ELISA TEST, DETECTADOT SYSTEM 2000 TOXO IGG TEST, RUBELLA IGG ELISA TEST and ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST.

Generated automatically from registry data and not verified by a human reviewer.