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Difco Laboratories, Inc.

United StatesFDA applicant, unverified

Devices
121

What Difco Laboratories, Inc. makes

Difco Laboratories, Inc. manufactures microbiological reagents and diagnostic tools, including differentiation disks for antibiotic susceptibility testing (e.g., vancomycin, clindamycin), spot test reagents (e.g., Voges-Proskauer), and specialized transport systems for pathogens (e.g., anaerobic transport pouches, viral transport packs). The portfolio also covers direct detection systems for infectious agents, such as the Chlamydia Direct Detection System, and coagulase testing strips for bacterial identification.

The company’s products are regulated under FDA’s Class I and Class II device classifications, with many cleared via the 510(k) pathway. These items are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.

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

Catalogue121

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  • Cefixime 5 Mcg Sensitivity Disks Ref K894829

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

  • Dispens-O-Disc Sparfloxacin Ref K971211

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

  • Bacto(R) Strep Group Kit Ref K870854

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

  • Enoxacin Ref K922794

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

  • Aztreonam 30 Mcg Sensitivity Disks Ref K870347

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

  • Difco Strep A Latex Test Ref K854978

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

  • Rubella-Cube(Tm) Ref K892051

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

  • Crp Slide Test Kit Ref K840699

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

  • Mono-Cube(Tm) Ref K890991

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

  • Spottest Oxidase Reagent Ref K840575

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

  • Uricheck Ref K860905

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

  • Minocycline 30 Mcg. Sensitivity Discs Ref K802178

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

  • Dryslide, Beta-Lactamase Ref K901784

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

  • Trimethoprim 5MCG. Sensitivity Discs Ref K801474

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

  • Spottest India Ink Ref K851184

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

  • Bacto Staphylococcus Latex Test Ref K843560

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

  • Spottest Nitrate Reagent C Ref K840581

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

  • Spottest Microdase Ref K870717

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

  • Cellmatics Rsv Detection System Ref K862321

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

  • Detect Group A Strep Test Ref K834582

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

  • Cellmatic Chlamydia Culture Confirm-Difco-1000 Ref K860292

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

Rows 101-121 of 121

Showing 101-121 of 121