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    FDA UDI In Commercial Distribution 🇺🇸 United States

    QBC Diagnostics

    DI: 00858092006215 · Model: 427420 · DRUCKER DIAGNOSTICS
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QBC Diagnostics
    Primary DI
    00858092006215
    Version / Model
    427420
    Catalog Number
    427420
    Company Name
    DRUCKER DIAGNOSTICS
    Labeler DUNS
    022156957
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2019-03-11
    Public Version Status
    Update
    Public Device Record Key
    08bbc352-d7c9-4323-8f90-13838b2723aa

    Device Description

    QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives and Centrifuge (115V)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    JSY Kit, Identification, Mycobacteria
    GKB Device, Automated Sedimentation Rate

    GMDN Terms

    Code Name
    42694 Biological stain kit IVD

    Identifiers

    Type ID
    Primary 00858092006215