BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set

    DI: 05060169690318 · Model: IS-4430 · 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-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set
    Primary DI
    05060169690318
    Version / Model
    IS-4430
    Company Name
    IMMUNODIAGNOSTIC SYSTEMS LIMITED
    Labeler DUNS
    494268600
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-01
    Public Version
    4
    Public Version Date
    2022-12-19
    Public Version Status
    Update
    Public Device Record Key
    192ee63d-c973-4607-8e8e-b19486d792c2

    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    41363 Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, control

    Identifiers

    Type ID
    Primary 05060169690318

    Customer Contacts

    Phone
    +4401915190660
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K111938 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store controls in an upright position
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius