BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ONE LAMBDA, INC

    Reg #: 3013058950 · FEI: 3013058950 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    ONE LAMBDA, INC
    Registration Number
    3013058950
    FEI Number
    3013058950
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Neuendorfstr. 25, room 03.206
    City
    Hennigsdorf Brandenburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    BK030003

    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 Lambda, Inc.
    Contact Name
    Angela Estany
    Address
    22801 Roscoe Blvd
    City
    West Hills
    State
    CA
    ZIP
    91304
    Country
    US
    Email
    [email protected]
    Phone
    747 4941862

    Products

    Device Name Product Code
    Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis PER
    Test, Qualitative, For Hla, Non-Diagnostic MZI
    Test, Leukocyte Typing LGO
    Apparatus, Electrophoresis, For Clinical Use JJN
    Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test QUK
    Station, Pipetting And Diluting, For Clinical Use JQW
    Stains, Hematology KQC
    Lymphocyte Separation Medium JCF

    Proprietary Names

    One Lambda HLA PRO UniMatch Plus Anti-B27 FITC/CD3PE Conjugated Monoclonal Antibody AllSet Gold SSP LABScreen for use with LABScan 3D LABScreen Multi HLA High Resolution SSP Unitray Terasaki Tissue Typing Trays and Lambda Monoclonal Trays Micro SSP Gel System SeCore™ CDx HLA Sequencing System HLA Fusion Software version 3 LABScreen Lambda Jet MT III, v 1.2 LABXpress Reflex Commander Pippeter Fluoroquench Staining/Quench Reagent Stain Fix Secore HLA Sequencing System and uType DX HLA Sequence Analysis Software Lympho-Kwik Fluorobeads UniTray SSP HLA Typing Kits HNA Genotyping HLA Fusion Software LABType SSO Typing Tests Micro SSP DNA Typing Tests LABType SSO DNA Typing Tests for use with LABScan 3D LABType XR and CWD DNA Typing Tests LABScreen™ Multi LABTypeTM XR and CWD DNA Typing Test Anti-B27 FITC Conjugated Monoclonal Antibody Lambda Cell Tray Lambda Antigen Trays FlowPRA

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198