BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MicroScan Dried Gram Negative ESBL Confirmation Panel - Imipenem

    Reg #: 2919016 · FEI: 2919016 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Beckman Coulter, Inc.
    Registration Number
    2919016
    FEI Number
    2919016
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2040 ENTERPRISE BLVD.
    City
    West Sacramento
    State
    CA
    ZIP
    95691
    Country
    US

    Regulatory Submissions

    510(k) Number
    K870074

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US

    Products

    Device Name Product Code
    Manual Antimicrobial Susceptibility Test Systems JWY

    Proprietary Names

    MicroScan Dried Gram Negative ESBL Confirmation Panel - Imipenem MicroScan Dried Gram Positive MIC/Combo Panels- Amoxicillin/K Clavulanate MicroScan Dried Gram Negative MIC/Combo Panels - Cefotetan MicroScan Dried Gram Negative MIC/Combo Panels - Imipenem MicroScan Dried Gram Negative ESBL Confirmation Panel - Cefotetan MicroScan Dried Gram Positive MIC/Combo Panels- Rifampin MicroScan Dried Gram Positive MIC/Combo Panels- Azithromycin MicroScan Dried Gram Positive MIC/Combo Panels- Imipenem MicroScan Dried Gram Negative MIC/Combo Panels - Ticarcillin/K. Clavulanate MicroScan Dried Gram Positive MIC/Combo Panels- Cefazolin MicroScan Dried Gram Positive MIC/Combo Panels- Cefuroxime

    Establishment Types

    Manufacture Medical Device