BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Image Navigator®

    DI: M74900IN2201 · Model: IN220 · IMMUNO CONCEPTS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Image Navigator®
    Primary DI
    M74900IN2201
    Version / Model
    IN220
    Catalog Number
    IN220
    Company Name
    IMMUNO CONCEPTS INC
    Labeler DUNS
    038271904
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-08
    Public Version
    5
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    49fd4657-1539-4227-afbc-2b21fa82ca88

    Device Description

    Automated microscope system for immunofluorescent determination of autoantibodies.

    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
    PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

    GMDN Terms

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

    Identifiers

    Type ID
    Primary M74900IN2201