BEUDAMED
    FDA Registration Active 🇺🇸 United States

    JJY Instrumentation Lab GEM Creatine Control

    Reg #: 1220649 · FEI: 1220649 · Expires 2025
    View on FDA
    Products
    12
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    BIONOSTICS, INC.
    Registration Number
    1220649
    FEI Number
    1220649
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 JACKSON RD.
    City
    Devens
    State
    MA
    ZIP
    01434
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061974

    Owner / Operator

    Firm Name
    BIONOSTICS, INC.
    Operator Number
    1220649
    Address
    7 JACKSON RD., --
    City
    Devens
    State
    MA
    Postal Code
    01434
    Country
    US
    Correspondent
    Yifei Wang

    Products

    Device Name Product Code
    Assay, Carboxyhemoglobin GHS
    Electrode, Ion Specific, Calcium JFP
    Instrument, Hematocrit, Automated GKF
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Control, Hematocrit GLK
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    System, Hemoglobin, Automated GKR
    Electrode, Ion Specific, Potassium CEM
    Acid, Lactic, Enzymatic Method KHP
    Glucose Oxidase, Glucose CGA
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Sodium JGS

    Proprietary Names

    JJY Instrumentation Lab GEM Creatine Control GLK Instrumentation Lab GEM Crit Check GLK Instrumentation Lab GEM Crit PVP Kit

    Establishment Types

    Manufacture Medical Device