BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    IRISpec

    DI: 10837461001973 · Model: CA/CB Twinset · IRIS INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IRISpec
    Primary DI
    10837461001973
    Version / Model
    CA/CB Twinset
    Catalog Number
    800-7211
    Company Name
    IRIS INTERNATIONAL, INC.
    Labeler DUNS
    098240690
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-07
    Public Version
    4
    Public Version Date
    2023-09-08
    Public Version Status
    Update
    Public Device Record Key
    68df8eac-5d16-4657-b807-6460c81e0088
    Distribution End Date
    2022-12-30

    Device Description

    IRISpec CA/CB Twinset

    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
    JJW Urinalysis Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    30219 Multiple urine analyte IVD, control

    Identifiers

    Type ID
    Primary 10837461001973