BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Optilite® Low Level Total Protein Controls

    DI: 05051700019392 · Model: NQ061.L.OPT · THE BINDING SITE GROUP LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Optilite® Low Level Total Protein Controls
    Primary DI
    05051700019392
    Version / Model
    NQ061.L.OPT
    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
    2024-10-30
    Public Version
    1
    Public Version Date
    2024-11-07
    Public Version Status
    New
    Public Device Record Key
    a9b54010-ea87-4873-bd2f-6374d0817389

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    53987 Total protein IVD, control

    Identifiers

    Type ID
    Primary 05051700019392

    Customer Contacts

    Phone
    +4401214569500
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius