BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TSH AccuBind ELISA Test System - 192 Wells

    DI: 00816870021799 · Model: 325-300 · MONOBIND, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    TSH AccuBind ELISA Test System - 192 Wells
    Primary DI
    00816870021799
    Version / Model
    325-300
    Catalog Number
    325-300B
    Company Name
    MONOBIND, INC.
    Labeler DUNS
    083155515
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-11
    Public Version
    2
    Public Version Date
    2024-09-16
    Public Version Status
    Update
    Public Device Record Key
    4194a298-697b-4b74-89a2-45ea21f8ca07

    Device Characteristics

    Single Use
    No
    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 00816870021799

    Customer Contacts

    Phone
    +1(949)951-2665
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K971780 000

    Device Sizes

    Type Value Unit Text
    Width 7.75 Inch

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius