BEUDAMED
    FDA Registration Active 🇺🇸 United States

    T2Dx Instrument

    Reg #: 3010097867 · FEI: 3010097867 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    T2 BIOSYSTEMS, INC.
    Registration Number
    3010097867
    FEI Number
    3010097867
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    101 Hartwell Ave
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN140019

    Owner / Operator

    Firm Name
    T2 Biosystems, Inc.
    Operator Number
    10049038
    Address
    101 Hartwell Avenue
    City
    Lexington
    State
    MA
    Postal Code
    02421
    Country
    US
    Correspondent
    Scott Blood

    Products

    Device Name Product Code
    Candida Species Nucleic Acid Detection System PII
    Instrumentation For Clinical Multiplex Test Systems NSU

    Proprietary Names

    T2Dx Instrument T2Candida Panel T2Bacteria Panel

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device