BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control

    DI: 00884883005341 · Model: OPRO-303 · Microgenics Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control
    Primary DI
    00884883005341
    Version / Model
    OPRO-303
    Company Name
    Microgenics Corporation
    Labeler DUNS
    122153799
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-01
    Public Version
    5
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    358ee909-08eb-4b59-b93e-2ed94c4d182c

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    47869 Multiple-type clinical chemistry analyte profile IVD, control

    Identifiers

    Type ID
    Primary 00884883005341