BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stratus CS Acute Care CTNI CalPak

    Reg #: 3002637618 · FEI: 3002637618 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Inc
    Registration Number
    3002637618
    FEI Number
    3002637618
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Point Of Care Headquarters, 333 Coney St
    City
    East Walpole
    State
    MA
    ZIP
    02032
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051650

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US

    Products

    Device Name Product Code
    Myoglobin, Antigen, Antiserum, Control DDR
    Immunoassay Method, Troponin Subunit MMI
    Calibrator, Secondary JIT
    Fluorometric Method, Cpk Or Isoenzymes JHX

    Proprietary Names

    Stratus CS Acute Care CTNI CalPak Stratus CS Acute Care MYO TestPak Stratus CS Acute Care CTNI TestPak Stratus CS Acute Care CKMB CalPak Stratus CS Acute Care CKMB TestPak Stratus CS Acute Care MYO CalPak

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility