BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NG-Test CARBA 5

    DI: 03701077400133 · Model: Kit of 20 tests for US · NG BIOTECH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    NG-Test CARBA 5
    Primary DI
    03701077400133
    Version / Model
    Kit of 20 tests for US
    Catalog Number
    NGB-CAR-S23-018
    Company Name
    NG BIOTECH
    Labeler DUNS
    264235114
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2019-12-02
    Public Version
    1
    Public Version Date
    2019-12-10
    Public Version Status
    New
    Public Device Record Key
    9c5d2de8-2e97-4ef9-a7b4-9c139aab5014

    Device Description

    Rapid test for the detection of carbapenemases KPC, OXA, VIM, IMP and NDM in a bacterial colony from culture.

    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
    PTJ Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

    GMDN Terms

    Code Name
    43685 Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit

    Identifiers

    Type ID
    Primary 03701077400133
    Unit of Use 03701077400140

    Customer Contacts

    Phone
    +33223301783
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K191889 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    4 – 30 Degrees Celsius