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    FDA UDI In Commercial Distribution 🇺🇸 United States

    ThunderBolt EIA (CLIA)

    DI: B35000300CLR0 · Model: 00300-CLR · Gold Standard Diagnostics Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ThunderBolt EIA (CLIA)
    Primary DI
    B35000300CLR0
    Version / Model
    00300-CLR
    Catalog Number
    00300-CLR
    Company Name
    Gold Standard Diagnostics Corporation
    Labeler DUNS
    790524891
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-31
    Public Version
    1
    Public Version Date
    2023-11-08
    Public Version Status
    New
    Public Device Record Key
    5690960a-4d56-4986-8830-314a99998c7f

    Device Description

    ThunderBolt EIA-CLIA (refurbished)

    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
    Yes
    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
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    GMDN Terms

    Code Name
    56718 Enzyme immunoassay (EIA) analyser IVD
    56701 Chemiluminescent immunoassay analyser IVD

    Identifiers

    Type ID
    Primary B35000300CLR0