BEUDAMED
    Product Code: DDX FDA class 1 21 CFR 866.5715

    Plasminogen, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting plasminogen, the inactive precursor of plasmin that, when activated, degrades fibrin clots, including antigen, antiserum, and control components for clinical laboratory immunoassays used to evaluate fibrinolytic capacity and diagnose plasminogen deficiency. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is DDX, regulated under 21 CFR 866.5715, within the Immunology specialty.

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    510(k)s
    10
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    10
    Years Active
    17

    Basic Information

    Product Code
    DDX
    Device Class
    FDA class 1
    Regulation Number
    866.5715
    Medical Specialty
    Immunology
    Review Panel
    HE
    Submission Type
    4

    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 10 510(k) clearances via K numbers.

    K Number Device Name
    K941346 PLASMINOGEN RID TEST KIT
    K884766 BERICHROM(R) PLASMINOGEN
    K864212 IL TEST 97573-15, PLASMINOGEN ASSAY
    K854572 COATEST PLASMINOGEN
    K850410 GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY
    K832591 DIACROM *PLG
    K812625 ACA PLASMINOGEN TEST PACK
    K811777 HELENA PLASMINOGEN QUIPLATE PROCEDURE
    K781478 PLASMINOGEN ASSAY
    K772085 LAS-R HUMAN PLASMINOGEN TEST

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.