BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    APL™ IgG ELISA Kit

    DI: B473LAPLKAPG00 · 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
    APL™ IgG ELISA Kit
    Primary DI
    B473LAPLKAPG00
    Version / Model
    IgG
    Catalog Number
    LAPL-K-AP-G-0
    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
    db941f30-b95e-480b-95ac-0cb61242ed35

    Device Description

    The APL™ IgG ELISA Kit is designed for the measurement of anticardiolipin antibodies of the IgG isotype.

    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
    55085 Phospholipid antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary B473LAPLKAPG00

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius