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    FDA UDI In Commercial Distribution 🇺🇸 United States

    ANA Test Kit

    DI: 10862534000324 · Model: 15-123 · ANTIBODIES INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ANA Test Kit
    Primary DI
    10862534000324
    Version / Model
    15-123
    Catalog Number
    15-123
    Company Name
    ANTIBODIES INCORPORATED
    Labeler DUNS
    048944128
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    9653da2a-41cd-4d58-a40b-8d80b1ddea14

    Device Description

    Antinuclear Antibody (ANA) Test Kit

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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

    Product Codes

    Code Name
    DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

    GMDN Terms

    Code Name
    54808 Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 10862534000324