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510(k) Data Aggregation

    K Number
    K001900
    Device Name
    ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
    Manufacturer
    HELIX DIAGNOSTICS, INC.
    Date Cleared
    2000-09-11

    (81 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    HELIX DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000489
    Device Name
    ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
    Manufacturer
    HELIX DIAGNOSTICS, INC.
    Date Cleared
    2000-04-05

    (51 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    HELIX DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K980337
    Device Name
    DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
    Manufacturer
    HELIX DIAGNOSTICS, INC.
    Date Cleared
    1998-05-12

    (104 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    HELIX DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamedix Immunosimplicity ANA (Is-ANA) Screen is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects in one well, total ANAs against double stranded DNA (dsDNA, nDNA), Histones, SSA/Ro, SSB/La, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2 ANAs. These reagents can be used either manually or in conjunction with the MAGO™ Automated EIA Processor [510(k) number K973177]. For In Vitro Diagnostic Use.
    Device Description
    The Diamedix Immunosimplicity ANA (Is-ANA) Screen is a qualitative enzyme immunoassay (EIA).
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    K Number
    K960091
    Device Name
    ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
    Manufacturer
    HELIX DIAGNOSTICS, INC.
    Date Cleared
    1996-03-20

    (69 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    HELIX DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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