BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ONE LAMBDA, INC.

    Reg #: 2024375 · FEI: 2024375 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    42
    Establishment Types
    4
    Classifications
    8

    Registration Details

    Registration Name
    ONE LAMBDA, INC.
    Registration Number
    2024375
    FEI Number
    2024375
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    22801 Roscoe Blvd.
    City
    West Hills
    State
    CA
    ZIP
    91304
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK840013

    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

    Products

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

    Proprietary Names

    Lambda Cell Tray AllSet Gold SSP HLA Fusion Software version 3 Fluoroquench Staining/Quench Reagent Stain Fix LABScreen for use with LABScan 3D Terasaki Tissue Typing Trays and Lambda Monoclonal Trays Lympho-Kwik Fluorobeads HNA Genotyping FlowPRA LABType XR and CWD DNA Typing Tests Secore HLA Sequencing System and uType DX HLA Sequence Analysis Software Anti-B27 FITC Conjugated Monoclonal Antibody LABScreen LABTypeTM XR and CWD DNA Typing Test LABType SSO DNA Typing Tests for use with LABScan 3D Micro SSP DNA Typing Tests HLA High Resolution SSP Unitray C1qScreen Negative Control Serum C1qScreen C1qScreen Class I Positive Control C1qScreen Class II Postivie Control SureTyper Software LinkSeq HLA Typing Kit AllType FASTplex NGS 11 Loci Flex Kit – 96 TypeStream Visual Software AllType Next Generation Sequencing (NGS) 11 Loci Amplification Kit AllType FASTplex NGS 11 Loci Kit – 48 LABScreen Multi Micro SSP Gel System SeCore™ CDx HLA Sequencing System HLA Fusion Software Anti-B27 FITC/CD3PE Conjugated Monoclonal Antibody LABScreen™ Multi UniTray SSP HLA Typing Kits UniMatch Plus Lambda Antigen Trays One Lambda HLA PRO Lambda Jet MT III, v 1.2 LABXpress Reflex Commander Pippeter LABType SSO Typing Tests

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility