BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IDS SHBG

    DI: 05060169691322 · Model: IS-5600 · IMMUNODIAGNOSTIC SYSTEMS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    IDS SHBG
    Primary DI
    05060169691322
    Version / Model
    IS-5600
    Company Name
    IMMUNODIAGNOSTIC SYSTEMS LIMITED
    Labeler DUNS
    494268600
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-26
    Public Version
    1
    Public Version Date
    2019-10-04
    Public Version Status
    New
    Public Device Record Key
    2053489b-0915-467f-a1c1-b63ef2deb756

    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
    CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

    GMDN Terms

    Code Name
    54360 Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 05060169691322

    Customer Contacts

    Phone
    +4401915190660
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K190121 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store the cartridge and calibrators in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius