BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QMS Topiramate Immunoassay Control set

    DI: 00884883011250 · Model: 0374181 · Microgenics Corporation
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QMS Topiramate Immunoassay Control set
    Primary DI
    00884883011250
    Version / Model
    0374181
    Company Name
    Microgenics Corporation
    Labeler DUNS
    122153799
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-04
    Public Version
    4
    Public Version Date
    2019-07-09
    Public Version Status
    Update
    Public Device Record Key
    f7553e5a-f2ef-4dff-a60a-7405dd12b1c6

    Device Characteristics

    Single Use
    Yes
    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
    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
    NWM Immunoassay, Anti-Seizure Drug
    LAS Drug Specific Control Materials

    GMDN Terms

    Code Name
    55235 Multiple-therapy therapeutic drug monitoring IVD, control

    Identifiers

    Type ID
    Primary 00884883011250