BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SPOTCHECK

    DI: 00725609000083 · Model: 80-8000-CA · ASTORIA-PACIFIC, INC.
    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
    SPOTCHECK
    Primary DI
    00725609000083
    Version / Model
    80-8000-CA
    Catalog Number
    80-8000-CA
    Company Name
    ASTORIA-PACIFIC, INC.
    Labeler DUNS
    623238615
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-14
    Public Version
    4
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    d18ec334-bcda-4577-ac65-f1c88460007f

    Device Description

    Biotinidase 50 Hour Reagent Kit

    Device Characteristics

    Single Use
    Yes
    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
    NAK System,Test,Biotinidase

    GMDN Terms

    Code Name
    52960 Biotinidase IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00725609000083

    Premarket Submissions

    Submission Number Supplement Number
    K010844 000