BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Thyroid Stimulating Hormone (TSH) ELISA

    DI: B24225TSHHUE010 · Model: 25-TSHHU-E01 · AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Thyroid Stimulating Hormone (TSH) ELISA
    Primary DI
    B24225TSHHUE010
    Version / Model
    25-TSHHU-E01
    Catalog Number
    25-TSHHU-E01
    Company Name
    AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
    Labeler DUNS
    784143778
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-03
    Public Version
    4
    Public Version Date
    2022-09-20
    Public Version Status
    Update
    Public Device Record Key
    4146ee1e-0d97-4368-ae63-166345d63bd5
    Distribution End Date
    2019-02-19

    Device Description

    The Thyroid Stimulating Hormone (TSH) ELISA is intended for use in the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.

    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

    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 B24225TSHHUE010

    Customer Contacts

    Phone
    800.592.5726
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius