BEUDAMED
    FDA Registration Active 🇺🇸 United States

    475030 Cannabinoid 50 ng Reagent (THC5 1 x 250)

    Reg #: 2050012 · FEI: 2050012 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    2050012
    FEI Number
    2050012
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    250 S Kraemer Blvd
    City
    BREA
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K944086

    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
    Calibrators, Drug Specific DLJ
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Enzyme Immunoassay, Cannabinoids LDJ

    Proprietary Names

    475030 Cannabinoid 50 ng Reagent (THC5 1 x 250) 445814 SYNCHRON Systems 200 ng/mL THC Urine Calibrator 445811 SYNCHRON Systems 100 ng/mL THC Urine Calibrator 465912 SYNCHRON Systems 75 ng/mL THC Urine Control 465939 SYNCHRON Systems 125 ng/mL THC Urine Control 465914 SYNCHRON Systems 20 ng/mL THC Urine Control 445809 SYNCHRON Systems 50 ng/mL THC Urine Calibrator

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility