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Flow Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
58

What Flow Laboratories, Inc. makes

Flow Laboratories, Inc. manufactures diagnostic reagents and laboratory equipment, including trypsin solutions, fluorescent antibody conjugates for viral detection (such as adenovirus and measles), and microbiological media like Enteric-Tek and Anaerobe-Tek. The portfolio also covers automated systems like the Titertek Microplate Washer and Titertek Multiskan plate reader, as well as consumables such as Jembec plates with antimicrobial agents and diluter/dispenser tools for laboratory workflows.

The company’s products are regulated under FDA classifications, with most falling under Class I and some under Class II. Devices are authorised via 510(k) clearances and, where applicable, Premarket Approval (PMA) applications. These products are listed in the FDA’s regulatory databases, and the company operates from the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue58

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  • Resp. Syncytial-Fa Labelled Preserum Ref K770808

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

  • Hi Chicken Antiserum Ref K760607

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

  • Resp. Syncytial-Fa Labellhd (8-301-Rf) Ref K770804

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

  • Ha Antigen Ref K760606

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

  • Titertek Multiskan Mcc Ref K844418

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

  • Titertek-Enterobac Rapid Automated Ref K842182

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

  • Titertek Autodrop Ref K812818

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

  • 3M Brand Microbial Profile System Ref N50538

    Active Regimes: PMA Registry: PMA Class:II

Showing 51-58 of 58