BEUDAMED
    Product Code: DAT FDA class 2 21 CFR 864.7340

    Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

    Hematology

    This is an immunological reagent kit for detecting fibrinogen and fibrin split products using peroxidase as an enzymatic conjugate, supporting enzyme-linked immunoassay analysis of fibrinolysis and coagulation disorders. The kit includes antigen, antiserum, and control components for use in hematology diagnostic laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAT, regulated under 21 CFR 864.7340, within the Hematology specialty.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    16

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    Basic Information

    Product Code
    DAT
    Device Class
    FDA class 2
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K924892 FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
    K781103 SPECTRASCAN