BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KFLC Kappa Free Light Chains REF URCIII 08896640190

    Reg #: 2032900 · FEI: 3004445302 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Diazyme Laboratories, Inc.
    Registration Number
    2032900
    FEI Number
    3004445302
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12889 GREGG CT
    City
    POWAY
    State
    CA
    ZIP
    92064
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181438

    Owner / Operator

    Firm Name
    Diazyme Laboratories, Inc.
    Operator Number
    9057184
    Address
    12889 Gregg Court, --
    City
    Poway
    State
    CA
    Postal Code
    92064
    Country
    US
    Correspondent
    Abhijit - Datta

    Products

    Device Name Product Code
    Kappa, Antigen, Antiserum, Control DFH
    Lambda, Antigen, Antiserum, Control DEH

    Proprietary Names

    KFLC Kappa Free Light Chains REF URCIII 08896640190 KFLC Kappa Free Light Chains REF URCII 08896542190 KFLC Kappa Free Light Chains REF URCI 08896534190 Diazyme Human Kappa Free Light Chain Calibrator Set Diazyme Human Lambda Free Light Chain Calibrator Set Diazyme Human Kappa/Lambda Free Light Chain Control Set LFLC Lambda Free Light Chains REF URCIII 08896631190 Diazyme Human Kappa Free Light Chain Assay Kappa-Lambda FLC Control Set REF 08896577190 Diazyme Human Lambda Free Light Chain Assay LFLC Lambda Free Light Chains REF URCII 08896658190 LFLC Lambda Free Light Chains REF URCI 08896569190

    Establishment Types

    Manufacture Medical Device