BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    T2Candida® 1.1 Cartridge Kit

    DI: M70890078170 · Model: 90-07817 · T2 BIOSYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    T2Candida® 1.1 Cartridge Kit
    Primary DI
    M70890078170
    Version / Model
    90-07817
    Company Name
    T2 BIOSYSTEMS, INC.
    Labeler DUNS
    803126320
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-25
    Public Version
    1
    Public Version Date
    2018-07-26
    Public Version Status
    New
    Public Device Record Key
    4221656f-1ae6-4638-9a46-30eba500aafc

    Device Description

    The T2Candida 1.1 Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    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
    PII Candida Species Nucleic Acid Detection System

    GMDN Terms

    Code Name
    52031 Multiple Candida species nucleic acid IVD, reagent

    Identifiers

    Type ID
    Primary M70890078170

    Customer Contacts

    Phone
    877-504-8282
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius