BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IFA T. gondii IgG Test System

    DI: 00845533001519 · Model: FA8001G · ZEUS SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IFA T. gondii IgG Test System
    Primary DI
    00845533001519
    Version / Model
    FA8001G
    Catalog Number
    FA8001G
    Company Name
    ZEUS SCIENTIFIC, INC.
    Labeler DUNS
    080953946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    c27bffdb-88f2-43ae-8e86-f129ffa36676

    Device Description

    The ZEUS IFA Toxoplasma gondii IgG Test System is designed to detect the presence of circulating T. gondii antibodies in human sera and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

    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
    52437 Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 00845533001519

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius