BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rapid Response

    DI: 00722066001950 · Model: TSH-CTRL-13V · BTNX Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rapid Response
    Primary DI
    00722066001950
    Version / Model
    TSH-CTRL-13V
    Company Name
    BTNX Inc
    Labeler DUNS
    251005005
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-16
    Public Version
    2
    Public Version Date
    2023-04-20
    Public Version Status
    Update
    Public Device Record Key
    e95bacce-8701-49b2-8c1b-79b020cbb29d

    Device Description

    Thyroid TSH Test Controls +/- Controls Serum 0.5 mL

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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 00722066001950

    Premarket Submissions

    Submission Number Supplement Number
    K030912 000