BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LAPL™ aB2GPI IgM HRP ELISA Kit

    DI: B473LAPLKHRPAB2GPI1M0 · Model: IgM · 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 IgM HRP ELISA Kit
    Primary DI
    B473LAPLKHRPAB2GPI1M0
    Version / Model
    IgM
    Catalog Number
    LAPL-K-HRP-AB2GPI-1M
    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
    167f9dbb-8a5b-41fa-8d79-420991577d76

    Device Description

    LAPL™ aB2GPI IgM HRP ELISA Kit for detection of IgM 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 B473LAPLKHRPAB2GPI1M0

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius