BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PathTezt®

    DI: 09551020410009 · Model: PTIA-2021 · BIOCYTECH CORPORATION SDN. BHD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PathTezt®
    Primary DI
    09551020410009
    Version / Model
    PTIA-2021
    Company Name
    BIOCYTECH CORPORATION SDN. BHD.
    Labeler DUNS
    865773902
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-11
    Public Version
    1
    Public Version Date
    2026-03-19
    Public Version Status
    New
    Public Device Record Key
    0aca88e2-e944-458e-9f20-e192953784dd

    Device Description

    PathTezt® Infinity fully automated cytology slide processor with Autoloader. Fully walk away systems which provides continuous loading of sample up to 120 samples per batch

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IEO Processor, Tissue, Automated

    GMDN Terms

    Code Name
    57859 Tissue processor IVD, automated/semi-automated

    Identifiers

    Type ID
    Primary 09551020410009