BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PGDx elio™ diversiPhi

    DI: 00192721001241 · Model: A0840101 · PERSONAL GENOME DIAGNOSTICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PGDx elio™ diversiPhi
    Primary DI
    00192721001241
    Version / Model
    A0840101
    Catalog Number
    A0840101
    Company Name
    PERSONAL GENOME DIAGNOSTICS INC.
    Labeler DUNS
    963427120
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-11
    Public Version
    1
    Public Version Date
    2020-05-19
    Public Version Status
    New
    Public Device Record Key
    451b1812-a96e-4c5c-9bc2-9b02a56cbc9b

    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
    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
    PFT Reagents For Molecular Diagnostic Test Systems

    GMDN Terms

    Code Name
    61273 Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 00192721001241