BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HEp-2000® IgG Fluorescent ANA-Ro Test System

    DI: M7498302RO1 · Model: 8302-Ro · IMMUNO CONCEPTS INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    HEp-2000® IgG Fluorescent ANA-Ro Test System
    Primary DI
    M7498302RO1
    Version / Model
    8302-Ro
    Catalog Number
    8302-Ro
    Company Name
    IMMUNO CONCEPTS INC
    Labeler DUNS
    038271904
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2026-02-09
    Public Version Status
    Update
    Public Device Record Key
    c41945f3-b2ac-4998-9e4f-2f117fd166b9

    Device Description

    Custom - HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 1400 Tests

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

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

    Identifiers

    Type ID
    Primary M7498302RO1