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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Automated Digital Morphology Analyzer DI-60

    DI: 07350040972021 · Model: CC286297 · Cellavision AB
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Automated Digital Morphology Analyzer DI-60
    Primary DI
    07350040972021
    Version / Model
    CC286297
    Catalog Number
    CC286297
    Company Name
    Cellavision AB
    Labeler DUNS
    508663101
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    5
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    94bd167b-12d7-4bdb-8171-db4ac2542d1a

    Device Description

    Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GKZ Counter, Differential Cell
    JOY Device, Automated Cell-Locating

    GMDN Terms

    Code Name
    61864 Cell morphology analyser IVD, automated/semi-automated

    Identifiers

    Type ID
    Primary 07350040972021

    Customer Contacts

    Phone
    +46464601600
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K092868 000