BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 00860002740003 · Model: PKF08 · LAB KINETICS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    00860002740003
    Version / Model
    PKF08
    Company Name
    LAB KINETICS LLC
    Labeler DUNS
    092773251
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-06
    Public Version
    4
    Public Version Date
    2022-03-08
    Public Version Status
    Update
    Public Device Record Key
    ab91a55d-9e8c-44fa-ae99-9233fe078dd1

    Device Description

    Incubating Kinetic Tube Reader for In Vitro Diagnostic (IVD) use, by professionals, in a clinical or laboratory setting.

    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
    JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

    GMDN Terms

    Code Name
    42625 Photometric/spectroscopic immunoassay analyser IVD

    Identifiers

    Type ID
    Primary 00860002740003