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510(k) Data Aggregation

    K Number
    K101319
    Device Name
    IMMULISA DSDNA ANTIBODY ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2010-12-09

    (212 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to double stranded DNA (dsDNA) in human serum, as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K083381
    Device Name
    EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2009-04-15

    (152 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or qualitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and EDTA or citrate plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K062183
    Device Name
    FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2006-11-21

    (113 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This assay is intended for the in-vitro measurement of specific, high avidity IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other serological test results and clinical findings.
    Device Description
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    K Number
    K040811
    Device Name
    VARELISA SSDNA ANTIBODIES, MODEL 14896
    Manufacturer
    PHARMACIA DEUTSCHLAND GMBH
    Date Cleared
    2004-05-13

    (45 days)

    Product Code
    LRM
    Regulation Number
    866.5100
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    Product Code :

    LRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa ssDNA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of anti-single stranded DNA (ssDNA) autoantibodies in serum or plasma. In conjunction with the Varelisa dsDNA Antibodies kit it assists in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases. The test is not definitive in isolation but has to be seen as one parameter in a multicriterion diagnostic process.
    Device Description
    Varelisa ssDNA Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ssDNA antibodies in human serum or plasma. Antibodies specific for ssDNA present in the patient sample bind to the antigen. The assay should be used in combination with the Varelisa dsDNA Antibodies. The test kit contains microplate strips coated with synthetic ssDNA, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, Sample Diluent and wash buffer.
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    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?
    Product Code :

    LRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000477
    Device Name
    MDI DS-DNA TEST
    Manufacturer
    MICRO DETECT, INC.
    Date Cleared
    2000-03-01

    (16 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994424
    Device Name
    DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2000-02-18

    (50 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamedix Is-anti-dsDNA an Enzyme Immunoassay (EIA) for the quantitative detection of IgG antibodies to double-stranded (ds) DNA in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
    Device Description
    The Is-anti-dsDNA Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of IgG antibodies to DNA in human serum.
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    K Number
    K993727
    Device Name
    BINDAZYME ANTI-DSDNA EIA KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1999-12-21

    (57 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This assay is intended for the in-vitro measurement of specific IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings.
    Device Description
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    K Number
    K984396
    Device Name
    LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
    Manufacturer
    BIO-RAD
    Date Cleared
    1998-12-18

    (9 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquichek Anti-dsDNA Control is intended for use as an unassayed quality control to monitor immunoassay procedures for the detection of dsDNA autoantibodies.
    Device Description
    Liquichek Anti-dsDNS Control is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
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    K Number
    K983422
    Device Name
    THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1998-11-18

    (50 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Product Code :

    LRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases. The dsDNA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies dsDNA.
    Device Description
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