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    FDA Registration Active 🇺🇸 United States

    Mesa Laboratories Bozeman Manufacturing Facility (Zoot)

    Reg #: 3013667284 · FEI: 3013667284 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    18
    Establishment Types
    4
    Classifications
    2

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    Registration Details

    Registration Name
    Mesa Laboratories Bozeman Manufacturing Facility (Zoot)
    Registration Number
    3013667284
    FEI Number
    3013667284
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    625 Zoot Way
    City
    Bozeman
    State
    MT
    ZIP
    59718
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093794

    Owner / Operator

    Firm Name
    MESA LABORATORIES, INC.
    Operator Number
    1720309
    Address
    12100 WEST 6TH AVE., --
    City
    Lakewood
    State
    CO
    Postal Code
    80228
    Country
    US

    Products

    Device Name Product Code
    Indicator, Biological Sterilization Process FRC
    Indicator, Physical/Chemical Sterilization Process JOJ

    Proprietary Names

    Smart-Read EZTest Biological Indicator Monitoring System Smart-Read EZTest Indicatore Biologico Auto-Contenuto ExpoSure Steam EZTest Biological Test Pack for Use in Steam Sterilizers ProChem EXT Spore Strip Biological Indicator EO/Dry Heat EZTest Indicatore Biologico Auto-Contenuto Getinge Assured Biological Indicators for Steam Sterilization EZTest Biological Indicator for Steam Sterilization Exposure Biological Indicator ProSpore Biological Indicator Mesa ProChem B-D 121 Bowie-Dick Test Pack Mesa ProChem B-D Test Pack Mesa Dry Heat Indicator Labels Smart-Read EZTest Steam Biological Test Pack with Instant Readout Integrator Spore Strip Biological Indicator Steam and Chemiclave EZTest Indicatore Biologico Auto-Contenuto per Sterilizzazione ad ossido di etilene EZTest Biological Indicator for EO Sterilization

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device