BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMMUNO-TROL

    DI: 03760170782089 · Model: CYTO · THERADIAG SA
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IMMUNO-TROL
    Primary DI
    03760170782089
    Version / Model
    CYTO
    Catalog Number
    HM 066US-2X05
    Company Name
    THERADIAG SA
    Labeler DUNS
    391123478
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-24
    Public Version
    1
    Public Version Date
    2018-10-25
    Public Version Status
    New
    Public Device Record Key
    4fd3494a-e293-40ec-88f1-274b46d5dcd8

    Device Description

    reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti-ribosomal antigen Ribo , Anti-mitochondrial antigen Mito .

    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

    GMDN Terms

    Code Name
    55035 Mitochondrial antibody M2 (anti-Mi2) IVD, control
    46766 Ribosomal phosphoprotein antibody IVD, control

    Identifiers

    Type ID
    Primary 03760170782089

    Customer Contacts

    Phone
    0164621012
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius