BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Secore HLA Sequencing System and uType DX HLA Sequence Analysis Software

    Reg #: 3013058950 · FEI: 3013058950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ONE LAMBDA, INC
    Registration Number
    3013058950
    FEI Number
    3013058950
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Neuendorfstr. 25, room 13.021, 13.017
    City
    Hennigsdorf Brandenburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    BK110038

    Owner / Operator

    Firm Name
    One Lambda, Inc.
    Operator Number
    2024375
    Address
    22801 Roscoe Blvd, --
    City
    West Hills
    State
    CA
    Postal Code
    91304
    Country
    US
    Correspondent
    Angela - Estany

    US Agent

    Business Name
    One Lamda Inc.
    Contact Name
    Angela Estany
    Address
    22801 Roscoe Blvd
    City
    West Hills
    State
    CA
    ZIP
    91304
    Country
    US
    Email
    [email protected]
    Phone
    747 4941175

    Products

    Device Name Product Code
    Test, Qualitative, For Hla, Non-Diagnostic MZI

    Proprietary Names

    Secore HLA Sequencing System and uType DX HLA Sequence Analysis Software

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198