BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Histofluor® Rodent LKS Fluorescent Antibody Test System

    DI: M7491202202R11 · Model: 12022-02R (1) · IMMUNO CONCEPTS INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Histofluor® Rodent LKS Fluorescent Antibody Test System
    Primary DI
    M7491202202R11
    Version / Model
    12022-02R (1)
    Catalog Number
    12022-02R (1)
    Company Name
    IMMUNO CONCEPTS INC
    Labeler DUNS
    038271904
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2021-06-08
    Public Version Status
    Update
    Public Device Record Key
    87a4dd10-31e1-4693-b296-0d05343aa43b
    Distribution End Date
    2019-11-01

    Device Description

    APCA Optional Positive Control 1 x 0.5 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
    55079 Intrinsic factor/parietal cell antibody IVD, control

    Identifiers

    Type ID
    Primary M7491202202R11