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    K Number
    K070763
    Device Name
    EUROIMMUN ANA IFA: HEP-20-10
    Manufacturer
    EUROIMMUN US LLC
    Date Cleared
    2007-05-22

    (63 days)

    Product Code
    DHN
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EUROIMMUN ANA IFA: HEP-20-10

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EUROIMMUN ANA IFA:HEp-20-10 is an indirect fluorescent antibody test for the qualitative or semiquantitative detection of antibodies against cell nuclei (ANA) in human serum and EDTA-plasma. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or any studies with AI or human readers. The document is a 510(k) clearance letter from the FDA for a device called "EUROIMMUN ANA IFA: Hep-20-10," which is an indirect fluorescent antibody test for detecting antibodies against cell nuclei.

    Therefore, I cannot provide the requested information.

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