BEUDAMED
    Product Code: PAR

    Test, Volatile Organic Compounds Breath Analysis

    Unknown

    The Volatile Organic Compounds Breath Analysis Test is a diagnostic device intended to aid in the diagnosis of grade 3 heart transplant rejection in patients who have received a heart transplant within the preceding year. It is intended to be used as an adjunct to, and not a substitute for, endomyocardial biopsy, and its use is limited to patients who have had an endomyocardial biopsy within the previous month. The device carries a device class of "f," indicating a special or biological regulatory pathway, with no assigned regulation number or standard medical specialty; it was reviewed by the Clinical Chemistry panel. It is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    PAR
    Medical Specialty
    Unknown
    Review Panel
    CH
    Submission Type
    6

    Device Characteristics

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

    Definition

    Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.