BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Thyrotropin (TSH) ELISA

    DI: 00840239052834 · Model: EIA-5283 · DRG International Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Thyrotropin (TSH) ELISA
    Primary DI
    00840239052834
    Version / Model
    EIA-5283
    Catalog Number
    EIA-5283
    Company Name
    DRG International Inc
    Labeler DUNS
    075150847
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-25
    Public Version
    1
    Public Version Date
    2023-09-04
    Public Version Status
    New
    Public Device Record Key
    b302adaa-46d0-4901-a751-0da584bccfa7

    Device Description

    The Quantitative Determination of Thyrotropin Concentration in Human Serum by a Microplate Immunoenzymometric assay

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

    GMDN Terms

    Code Name
    54383 Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00840239052834

    Customer Contacts

    Phone
    1 973-564-7555
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius