BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Xmatrx® Infinity

    DI: 00810119676290 · Model: AS4000RX · BIOGENEX LABORATORIES
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Xmatrx® Infinity
    Primary DI
    00810119676290
    Version / Model
    AS4000RX
    Catalog Number
    AS4000RX
    Company Name
    BIOGENEX LABORATORIES
    Labeler DUNS
    042697045
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-20
    Public Version
    1
    Public Version Date
    2023-04-28
    Public Version Status
    New
    Public Device Record Key
    e07de656-d619-4145-8145-df51e4146907

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KEY Stainer, Tissue, Automated

    GMDN Terms

    Code Name
    15599 Microscope slide stainer IVD

    Identifiers

    Type ID
    Primary 00810119676290