BEUDAMED
    FDA Registration Active 🇺🇸 United States

    475030 Cannabinoid 50 ng Reagent (THC5 1 x 250)

    Reg #: 2050010 · FEI: 2050010 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    2050010
    FEI Number
    2050010
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2470 Faraday Ave
    City
    CARLSBAD
    State
    CA
    ZIP
    92010
    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

    Manufacture Medical Device for Another Party (Contract Manufacturer)