BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NMP22 BladderChek Control Kit

    DI: 00811877011552 · Model: D1250 · Alere Scarborough, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NMP22 BladderChek Control Kit
    Primary DI
    00811877011552
    Version / Model
    D1250
    Company Name
    Alere Scarborough, Inc.
    Labeler DUNS
    154148498
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-08
    Public Version
    2
    Public Version Date
    2023-09-12
    Public Version Status
    Update
    Public Device Record Key
    6db59424-2a8c-41c1-ab96-d74c39aeb663

    Device Description

    NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control for the NMP22 BladderChek Test.

    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
    MMW System, Test, Tumor Marker, Monitoring, Bladder

    GMDN Terms

    Code Name
    60574 Nuclear matrix protein 22 IVD, control

    Identifiers

    Type ID
    Primary 00811877011552

    Premarket Submissions

    Submission Number Supplement Number
    K021231 000