BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ANCA Test System

    DI: M749100211121 · Model: 10021-11 (2) · 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
    M749100211121
    Version / Model
    10021-11 (2)
    Catalog Number
    10021-11 (2)
    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
    4
    Public Version Date
    2025-06-03
    Public Version Status
    Update
    Public Device Record Key
    d2e92ba6-f1a5-49e6-955c-6b631fc78fc2

    Device Description

    pANCA Positive Control - 2 x 1 ml.

    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
    55065 Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

    Identifiers

    Type ID
    Primary M749100211121