BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INFINITY™ Low Control Solution

    DI: 00885502015000 · Model: IGM-0024 · U.S. DIAGNOSTICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INFINITY™ Low Control Solution
    Primary DI
    00885502015000
    Version / Model
    IGM-0024
    Company Name
    U.S. DIAGNOSTICS INC.
    Labeler DUNS
    828116728
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-24
    Public Version
    1
    Public Version Date
    2018-10-25
    Public Version Status
    New
    Public Device Record Key
    18ac0edc-6441-4170-990f-3bf23f465926

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Primary 00885502015000

    Customer Contacts

    Phone
    866-216-5308
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K082201 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    46 – 86 Degrees Fahrenheit