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Litton Bionetics

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Devices
15

What Litton Bionetics makes

Litton Bionetics manufactures diagnostic test kits for detecting and quantifying antibodies and antigens related to infectious diseases. Their products include immunoassay kits for screening and titration of toxoplasmosis, herpes simplex virus (HSV), cytomegalovirus (CMV), rubella, rotavirus, and Epstein-Barr virus (EBV) markers, using fluorescent and enzyme-based detection methods.

The company’s portfolio consists of Class I and Class II devices, with several products listed via the FDA’s 510(k) pathway. These diagnostic tools are intended for in vitro use and are regulated under US medical device standards. The manufacturer is based in the United States.

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

Catalogue15

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  • Toxo Bio-Bead Screen Kit Ref K791611

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

  • Hsv Bio-Bead Screen Kit Ref K791614

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

  • Cmv Rq Bio-Enzabead Kit Ref K831343

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

  • Hsv Bio-Bead Titration Kit Ref K801721

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

  • Rubella Rq Bio-Enzabead Kit Ref K821804

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

  • Cmv Bio-Bead Screen Kit Ref K791612

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

  • Eb-Vca, Test, Antibody, Fluorescent Ref K780925

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

  • Rotavirus Bio-Enzabead Screen Kit Ref K834443

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

  • Ebna Acif Kit Ref K840417

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

  • Rubella Bio-Bead Titration Kit Ref K800789

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

  • Toxo Bio-Bead Titration Kit Ref K801720

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

  • Cmv Bio-Bead Titration Kit Ref K801722

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

  • Ebv-M Kit Ref K822985

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

  • Rubella Bio-Bead Screen Kit Ref K791610

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

  • Torch Bio-Bead Screen Kit Ref K791618

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

Rows 1-15 of 15

Frequently asked questions

How many devices does Litton Bionetics have in the registry?

The registry currently lists 15 devices for Litton Bionetics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Litton Bionetics's devices?

Among its 15 most recently registered devices, Litton Bionetics has devices listed in FDA 510(k) (15 devices).

What risk classes do Litton Bionetics's devices fall under?

Among its 15 most recently registered devices, the classes recorded for Litton Bionetics's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Litton Bionetics in the registry?

The most recently registered devices listed for Litton Bionetics include TOXO BIO-BEAD SCREEN KIT, HSV BIO-BEAD SCREEN KIT, CMV RQ BIO-ENZABEAD KIT and HSV BIO-BEAD TITRATION KIT.

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