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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Human Apolipoprotein A-1 (Apo A-1) kit for use on SPAPLUS

    DI: 05051700016872 · Model: NK085.S · THE BINDING SITE GROUP LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Human Apolipoprotein A-1 (Apo A-1) kit for use on SPAPLUS
    Primary DI
    05051700016872
    Version / Model
    NK085.S
    Company Name
    THE BINDING SITE GROUP LIMITED
    Labeler DUNS
    347045614
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    79d485c8-4c04-4402-851b-b56477bd69bd

    Device Characteristics

    Single Use
    No
    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
    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
    JHN Turbidimetric Method, Lipoproteins

    GMDN Terms

    Code Name
    53443 Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 05051700016872

    Customer Contacts

    Phone
    +4401214569500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K950383 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius