BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Optilite Alpha-2-macroglobulin Kit

    DI: 05051700017480 · Model: NK039.OPT.A · THE BINDING SITE GROUP LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Optilite Alpha-2-macroglobulin Kit
    Primary DI
    05051700017480
    Version / Model
    NK039.OPT.A
    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
    0f84bf85-3e91-483b-8f68-dea33484a61a

    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
    DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    53925 Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 05051700017480

    Customer Contacts

    Phone
    +4401214569500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K140664 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius