BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monogen 150 TESTS

    DI: 08426950585350 · Model: 3000-1002 · BIOKIT, S.A.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monogen 150 TESTS
    Primary DI
    08426950585350
    Version / Model
    3000-1002
    Company Name
    BIOKIT, S.A.
    Labeler DUNS
    460055742
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    0da48252-fa39-4b4b-9037-9813e45e6bfb

    Device Description

    3 x 1.4 ml REAGENT 1 x 2.0 ml CONTROL + 1 x 2.0 ml CONTROL – 3 x 9 SLIDES

    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
    KTN System, Test, Infectious Mononucleosis

    GMDN Terms

    Code Name
    49688 Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination

    Identifiers

    Type ID
    Primary 08426950585350

    Customer Contacts

    Phone
    1-800-926-3353
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K874678 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius