BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rapid Response

    DI: 00722066001646 · Model: TSH-13C20 · BTNX Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    Rapid Response
    Primary DI
    00722066001646
    Version / Model
    TSH-13C20
    Catalog Number
    TSH-13C20
    Company Name
    BTNX Inc
    Labeler DUNS
    251005005
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2016-10-25
    Public Version
    4
    Public Version Date
    2023-04-20
    Public Version Status
    Update
    Public Device Record Key
    7faf1112-0890-4223-83a2-ed47af810ea2

    Device Description

    Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are for the qualitative detection of TSH in serum, plasma or whole blood.

    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 00722066001646
    Unit of Use 00722066004319

    Premarket Submissions

    Submission Number Supplement Number
    K030912 000