BEUDAMED
    FDA Registration Active 🇺🇸 United States

    directCheck Whole Blood Citrated PT/APTT Control

    Reg #: 1220649 · FEI: 1220649 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    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
    K020798

    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
    System, Multipurpose For In Vitro Coagulation Studies JPA

    Proprietary Names

    directCheck Whole Blood Citrated PT/APTT Control GEM Check Citrated PT Control GEM Check PT Control GEM Check APTT Control directCheck Whole Blood PT Control directCheck Whole Blood Citrated PT Control GEM Check ACT Low Range Control directCheck Whole Blood APTT Control GEM Check ACT Control

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)