BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ANCA Test System

    DI: M7490083101 · Model: 8310 · IMMUNO CONCEPTS INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ANCA Test System
    Primary DI
    M7490083101
    Version / Model
    8310
    Catalog Number
    8310
    Company Name
    IMMUNO CONCEPTS INC
    Labeler DUNS
    038271904
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2026-01-13
    Public Version Status
    Update
    Public Device Record Key
    813e5250-e185-4098-b3ca-9c69ae36eac0

    Device Description

    Custom - ANCA BP FA Test System - Formalin Fixed Substrate - 1400 Tests

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    55061 Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary M7490083101