BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ID 32 STAPH

    DI: 03573026588601 · Model: ID 32 STAPH · BIOMERIEUX SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ID 32 STAPH
    Primary DI
    03573026588601
    Version / Model
    ID 32 STAPH
    Company Name
    BIOMERIEUX SA
    Labeler DUNS
    276816717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-10
    Public Version
    1
    Public Version Date
    2020-04-20
    Public Version Status
    New
    Public Device Record Key
    c55e49bb-f364-4e5e-a14c-80e8e608e6ad

    Device Description

    ID 32 STAPH is a standardized system for the identification of the genera Staphylococcus, Micrococcus and related genera, Rothia and Aerococcus

    Device Characteristics

    Single Use
    Yes
    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
    JWX KIT, SCREENING, STAPHYLOCOCCUS AUREUS

    GMDN Terms

    Code Name
    50419 Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit

    Identifiers

    Type ID
    Package 03573026066499
    Primary 03573026588601

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius