BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MAS Omni•IMMUNE PRO Max, Level 1

    DI: 00884883009349 · Model: OPROM-101 · Microgenics Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MAS Omni•IMMUNE PRO Max, Level 1
    Primary DI
    00884883009349
    Version / Model
    OPROM-101
    Company Name
    Microgenics Corporation
    Labeler DUNS
    122153799
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-12
    Public Version
    1
    Public Version Date
    2025-08-20
    Public Version Status
    New
    Public Device Record Key
    b3b1659e-cdd9-450d-b9c1-76975bf2ca03

    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 00884883009349