BEUDAMED
    Product Code: MZO FDA class 2

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    Unknown

    The Hepatitis C Virus (HCV) Enzyme Linked Immunosorbent Assay is an in vitro diagnostic test used to detect antibodies against HCV in patient serum or plasma, supporting the diagnosis of hepatitis C infection. HCV testing is critical for both clinical diagnosis and blood donor screening. Classified as FDA Class 2, it requires 510(k) premarket clearance. This device is reviewed by the Microbiology panel.

    View on FDA
    510(k)s
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    MZO
    Device Class
    FDA class 2
    Medical Specialty
    Unknown
    Review Panel
    MI
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K221693 Elecsys Anti-HCV II (08837031190)

    FEI Numbers

    This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.