BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anti-T. gondii IgM

    DI: 00845533002516 · Model: 8Z8651M · ZEUS SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Anti-T. gondii IgM
    Primary DI
    00845533002516
    Version / Model
    8Z8651M
    Catalog Number
    8Z8651M
    Company Name
    ZEUS SCIENTIFIC, INC.
    Labeler DUNS
    080953946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-17
    Public Version
    1
    Public Version Date
    2025-12-25
    Public Version Status
    New
    Public Device Record Key
    08709dd3-b89e-4f76-8532-9cf9033d8290

    Device Description

    The Anti-T. gondii IgM is an enzyme-linked immunosorbent assay designed for the presumptive qualitative detection of IgM antibodies to Toxoplasma plasma gondii in human serum and for the presumptive diagnosis of acute, recent, or reactive Toxoplasma gondii infection. To adequately assess the patient’s serological status, testing must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. This product is not FDA cleared (approved) for use in screening blood or plasma donors. This assay’s performance has not been established for screening of prenatal women or newborns.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    52440 Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00845533002516

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius