BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DBC Free Testosterone ELISA

    DI: B261CANFTE260LC80 · Model: CAN-FTE-260LC8 · Diagnostics Biochem Canada Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    DBC Free Testosterone ELISA
    Primary DI
    B261CANFTE260LC80
    Version / Model
    CAN-FTE-260LC8
    Catalog Number
    CAN-FTE-260LC8
    Company Name
    Diagnostics Biochem Canada Inc
    Labeler DUNS
    207718438
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-10
    Public Version
    2
    Public Version Date
    2023-05-03
    Public Version Status
    Update
    Public Device Record Key
    a19f7c8b-1e9d-49db-a815-24deb54c68e2

    Device Description

    For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use.

    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
    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
    CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

    GMDN Terms

    Code Name
    54181 Free testosterone IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary B261CANFTE260LC80

    Customer Contacts

    Phone
    1-519-681-8731
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K030730 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius