BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ion PGM™ 318 Dx Chip Kit

    DI: 10190302006255 · Model: A18937 · LIFE TECHNOLOGIES CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ion PGM™ 318 Dx Chip Kit
    Primary DI
    10190302006255
    Version / Model
    A18937
    Company Name
    LIFE TECHNOLOGIES CORPORATION
    Labeler DUNS
    080131636
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-14
    Public Version
    5
    Public Version Date
    2019-10-23
    Public Version Status
    Update
    Public Device Record Key
    87e6b41e-b4b4-40f8-bbf4-6c9c1631b5e4

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Expiration Date
    No
    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
    60120 Nucleic acid hybridization detection IVD, reagent

    Identifiers

    Type ID
    Primary 10190302006255