BEUDAMED
    Product Code: NVA FDA class 2 21 CFR 866.6010

    Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma

    Immunology

    The Soluble Mesothelin-Related Peptides Cancer Monitoring Test System for Mesothelioma is a diagnostic device used to monitor mesothelioma cancer patients after therapy for disease progression, used in conjunction with other diagnostic modalities. Mesothelin-related peptides in serum or plasma serve as biomarkers for monitoring treatment response in mesothelioma. It is an FDA Class 2 device regulated under 21 CFR 866.6010 in the Immunology specialty, with product code NVA, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.

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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
    NVA
    Device Class
    FDA class 2
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    Definition

    MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.