BEUDAMED
    FDA Registration Active 🇺🇸 United States

    APOC i-STAT TriControls Calibration Verification Kit

    Reg #: 1220649 · FEI: 1220649 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    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
    K972868

    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
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    APOC i-STAT TriControls Calibration Verification Kit APOC i-STAT CHEM 8+ Calibration Verifier Kit APOC i-STAT 1 Controls APOC i-STAT 1 Calibration Verification Kit APOC i-STAT CHEM 8+ Control

    Establishment Types

    Manufacture Medical Device