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    K Number
    K013432
    Device Name
    IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    2001-11-29

    (45 days)

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

    IMMUNO CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum. This test system is to be used as an aid in the diagnosis of systemic lupus erythematosus.
    Device Description
    This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum.
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    K Number
    K013283
    Device Name
    RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    2001-11-14

    (43 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMUNO CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is an enzyme immunoassay test system for the detection of antibodies to Proteinase 3 (PR3) in human serum. This test system is to be used as an aid in the detection of antibodies associated with Wegener's granulomatosis and other vasculitides.
    Device Description
    This is an enzyme immunoassay for the detection of antibodies to Proteinase 3 (PR3) in human serum.
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    K Number
    K013285
    Device Name
    RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    2001-11-14

    (43 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMUNO CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides.
    Device Description
    This is an enzyme immunoassay for the detection of antibodies to myeloperoxidase (MPO) in human serum.
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    K Number
    K992041
    Device Name
    RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    1999-07-23

    (36 days)

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

    IMMUNO CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is an enzyme immunoassay test system for the detection of antinuclear antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.
    Device Description
    This is an enzyme immunoassay for the detection of antinuclear antibodies in human serum.
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    K Number
    K983924
    Device Name
    HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    1998-12-18

    (44 days)

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

    IMMUNO CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is an indirect immunoenzyme antibody test for the semi-quantitative detection of antinuclear antibodies in human serum, with specific identification of autoantibodies to the SS-A/Ro antigen. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease. The results from this assay can be used as an aid in the diagnosis of autoimmune diseases.
    Device Description
    This is an indirect immunoenzyme antibody test for the semi-quantitative detection of antinuclear antibody in human serum. The transfected HEP-2 cell line allows for the identification of anti-SS-A/Ro antibodies because of the unique staining pattern that these antibodies show on this cell line.
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    K Number
    K972145
    Device Name
    HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    1998-02-24

    (263 days)

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

    IMMUNO CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This test system is for in vitro diagnostic use for the detection of antinuclear antibodies in human serum, with specific identification of autoantibodies to the SS-A/Ro antigen. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease. The results from this assay can be used as an aid in the diagnosis of autoimune diseases.
    Device Description
    This is an indirect fluorescent antibody test for the semi-quantitative detection of antinuclear antibody in human serum. The transfected HEP-2 cell line allows for the identification of anti-SS-A/Ro antibodies because of the unique staining pattern that these antibodies show on this cell line.
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    K Number
    K974463
    Device Name
    IMMUNO CONCEPTS ANCA TEST SYSTEM
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    1998-02-09

    (75 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMUNO CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is an in vitro diagnostic test system for thedetection and Semi-quantitation of tagsesses oblic cytoplasmic antibodies in human serum This test system is to be used as an aid in the detection of antibodies associated with autoimmune vasculitis, Wegener's granulomatosis, microscopic polyarteritis, and idiopathic crescentic glomerulonephritis.
    Device Description
    This is an indirect fluorescent antibody test for the semi-quantitative detection of antineutrophil cytoplasmic antibody in human serum
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    K Number
    K974478
    Device Name
    IMMUNO CONCEPTS ANCA TEST SYSTEMS
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    1998-02-09

    (75 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMUNO CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This test system is for in vitro diagnostic use for the detection of antineutrophil cytoplasmic antibody in human serum. This test system is to be used as an aid in the detection of antibodies associated with autoimmune vasculitis, Wegener's granulomatosis, microscopic polyarteritis, and idiopathic crescentic glomerulonephritis.
    Device Description
    This is an indirect fluorescent antibody test for the semi-quantitative detection of antineutrophil cytoplasmic antibody in human serum
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    K Number
    K963275
    Device Name
    RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    1996-09-13

    (24 days)

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

    IMMUNO CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum. The results from this assay can be used as an aid in the diagnosis of autoimmune diseases.
    Device Description
    This is an enzyme immunoassay for the detection of antibodies to extractable nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum.
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    K Number
    K955602
    Device Name
    RELSIA SCL-70 ANTIBODY TEST SYSTEM
    Manufacturer
    IMMUNO CONCEPTS, INC.
    Date Cleared
    1996-04-19

    (133 days)

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

    IMMUNO CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Scl-70 in human serum.
    Device Description
    This is an enzyme immunoassay for the detection of antibodies to nuclear antigen Scl-70 in human serum.
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