BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rightest Control Solution Wiz

    Reg #: 3006755541 · FEI: 3006755541 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BIONIME USA CORPORATION
    Registration Number
    3006755541
    FEI Number
    3006755541
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1450 E. Spruce Street, Bldg. #B
    City
    Ontario
    State
    CA
    ZIP
    91761
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092052

    Owner / Operator

    Firm Name
    BIONIME USA CORPORATION
    Operator Number
    10024947
    Address
    1450 E. Spruce Street, Bldg. #B
    City
    Ontario
    State
    CA
    Postal Code
    91761
    Country
    US

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    Rightest Control Solution Wiz Rightest Control Solution GC550 GE GE100 Blood Glucose Monitoring System McKesson Quintet AC Control Solution GE GM550 Blood Glucose Monitoring System Rightest GM250S Blood Glucose Monitoring System PSS World Medical Quintet AC Blood Glucose Monitoring System McKesson Quintet AC Blood Glucose Monitoring System Rightest GM250 Blood Glucose Monitoring System McKesson Quintet AC Blood Glucose Test Strip Rightest GM260 Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System GT100 GE 333 Control Solution Rightest Blood Glucose Monitoring System, Model GM550

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198