BEUDAMED
    FDA Registration Active 🇺🇸 United States

    C1qScreen Class I Positive Control

    Reg #: 2024375 · FEI: 2024375 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ONE LAMBDA, INC.
    Registration Number
    2024375
    FEI Number
    2024375
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    22801 Roscoe Blvd.
    City
    West Hills
    State
    CA
    ZIP
    91304
    Country
    US

    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

    Proprietary Names

    C1qScreen Class I Positive Control C1qScreen C1qScreen Negative Control Serum C1qScreen Class II Postivie Control SureTyper Software TypeStream Visual Software LinkSeq HLA Typing Kit AllType Next Generation Sequencing (NGS) 11 Loci Amplification Kit AllType FASTplex NGS 11 Loci Flex Kit – 96 AllType FASTplex NGS 11 Loci Kit – 48

    Establishment Types

    Manufacture Device in the United States for Export Only