BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BTA stat

    DI: 00855574005353 · Model: 661203 · POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BTA stat
    Primary DI
    00855574005353
    Version / Model
    661203
    Company Name
    POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
    Labeler DUNS
    078413594
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    e593736b-4e6f-4370-9e2c-17d908e3f074

    Device Description

    BTA stat - Controls - US Labeled 15 Deteriminations

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    54562 Bladder tumour associated antigen IVD, control

    Identifiers

    Type ID
    Primary 00855574005353

    Premarket Submissions

    Submission Number Supplement Number
    K974845 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius