BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    T-3

    DI: 00840239056979 · Model: HYE-5697 · DRG International Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    T-3
    Primary DI
    00840239056979
    Version / Model
    HYE-5697
    Catalog Number
    HYE-5697
    Company Name
    DRG International Inc
    Labeler DUNS
    075150847
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-13
    Public Version
    1
    Public Version Date
    2024-08-21
    Public Version Status
    New
    Public Device Record Key
    458a1fc0-4cd0-4326-87a1-9831d877ca6f

    Device Description

    The DRG:Hybrid-XL T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of T3

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CDP Radioimmunoassay, Total Triiodothyronine

    GMDN Terms

    Code Name
    61252 Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00840239056979

    Customer Contacts

    Phone
    973-564-7555
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius