BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ANA/HEp-2 IgG IFA 180 Test

    DI: G5229023451 · Model: 902345 · Hemagen Diagnostics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ANA/HEp-2 IgG IFA 180 Test
    Primary DI
    G5229023451
    Version / Model
    902345
    Company Name
    Hemagen Diagnostics, Inc.
    Labeler DUNS
    147827216
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-05
    Public Version
    2
    Public Version Date
    2026-02-09
    Public Version Status
    Update
    Public Device Record Key
    c73ac5fa-c29f-458d-8d45-3ba38b7005c5

    Device Description

    For the detection and titration of anti-nuclear IgG antibodies in human sera

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    Yes
    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

    Product Codes

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

    GMDN Terms

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

    Identifiers

    Type ID
    Primary G5229023451

    Customer Contacts

    Phone
    443 367 5500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K841127 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius