BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    125I TSH Receptor Antibody Kit (TRAb PEG) (With Calibrators)

    DI: B126KR61450 · Model: KR6145 · KRONUS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    125I TSH Receptor Antibody Kit (TRAb PEG) (With Calibrators)
    Primary DI
    B126KR61450
    Version / Model
    KR6145
    Catalog Number
    KR6145
    Company Name
    KRONUS, INC.
    Labeler DUNS
    181070814
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-09-24
    Public Version Status
    Update
    Public Device Record Key
    e5007d78-f81b-412a-aba4-fd557a60fa52

    Device Description

    A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JZO System, Test, Thyroid Autoantibody

    GMDN Terms

    Code Name
    54392 Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay

    Identifiers

    Type ID
    Primary B126KR61450

    Customer Contacts

    Phone
    800-457-6687
    Email
    [email protected]