BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LAPL™ aB2GPI IgG HRP ELISA Kit

    DI: B473LAPLKHRPAB2GPI1G0 · Model: IgG · Louisville APL Diagnostics, Inc.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LAPL™ aB2GPI IgG HRP ELISA Kit
    Primary DI
    B473LAPLKHRPAB2GPI1G0
    Version / Model
    IgG
    Catalog Number
    LAPL-K-HRP-AB2GPI-1G
    Company Name
    Louisville APL Diagnostics, Inc.
    Labeler DUNS
    018417647
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-26
    Public Version
    1
    Public Version Date
    2023-01-03
    Public Version Status
    New
    Public Device Record Key
    c9ea61ec-b757-4344-9914-2036e7f636d2

    Device Description

    LAPL™ aB2GPI IgG HRP ELISA Kit for detection of IgG anti-B2 Glycoprotein I Antibodies.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    54879 Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary B473LAPLKHRPAB2GPI1G0