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510(k) Data Aggregation

    K Number
    K041043
    Device Name
    VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
    Manufacturer
    PHARMACIA DEUTSCHLAND GMBH
    Date Cleared
    2004-07-02

    (71 days)

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

    PHARMACIA DEUTSCHLAND GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa PR3 ANCA EIA kit is designed for the semi-quantitative and qualitative determination of proteinase 3 anti neutrophil cytoplasmic antibodies (PR3 ANCA) in human serum or plasma to aid in the diagnosis of Wegener's granulomatosis.
    Device Description
    Varelisa PR3 ANCA is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of PR3 ANCA in human serum or plasma. The test kit contains microplate strips coated with human purified PR3 antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.
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    K Number
    K040810
    Device Name
    VARELISA HISTONE ANTIBODIES, MODEL 16496
    Manufacturer
    PHARMACIA DEUTSCHLAND GMBH
    Date Cleared
    2004-05-14

    (46 days)

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

    PHARMACIA DEUTSCHLAND GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa Histone Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgG and IgM antibodies to histone in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE) or druginduced lupus erythematosus (DIL).
    Device Description
    Varelisa Histone Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of histone antibodies in human serum or plasma. The wells of a microtiterplate are coated with human histone antigen. Antibodies specific for histones present in the patient sample bind to the antigen. In a second step the enzyme labeled second antibody (conjugate) binds to the antigen-antibody complex which leads to the formation of an enzyme labeled conjugate-antibody-antigen complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution. The rate of color formation from the chromogen is a function of the amount of conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHARMACIA DEUTSCHLAND GMBH

    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
    K040449
    Device Name
    VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
    Manufacturer
    PHARMACIA DEUTSCHLAND GMBH
    Date Cleared
    2004-05-11

    (81 days)

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

    PHARMACIA DEUTSCHLAND GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa B2-Glycoprotein I IgG Antibodies EIA kit is designed for the semiguantitative and qualitative determination of ß2-glycoprotein I IgG antibodies in serum or plasma. The presence of ß2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.
    Device Description
    Varelisa B .- Glycoprotein I IgG Antibodies Assay is an indirect The noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of ß2-glycoprotein I IgG antibodies in serum or plasma. The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.
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    K Number
    K040450
    Device Name
    VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
    Manufacturer
    PHARMACIA DEUTSCHLAND GMBH
    Date Cleared
    2004-05-11

    (81 days)

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

    PHARMACIA DEUTSCHLAND GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa ß2-Glycoprotein I IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgA antibodies in serum or plasma. The presence of B2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.
    Device Description
    The Varelisa B2-Glycoprotein I IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgA antibodies in serum or plasma. The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.
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    K Number
    K040451
    Device Name
    VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
    Manufacturer
    PHARMACIA DEUTSCHLAND GMBH
    Date Cleared
    2004-05-11

    (81 days)

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

    PHARMACIA DEUTSCHLAND GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa ß2-Glycoprotein I IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgM antibodies in serum or plasma. The presence of ß2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.
    Device Description
    The Varelisa B2-Glycoprotein I IgM Antibodies Assay is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of B2-glycoprotein I IgM antibodies in serum or plasma. The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.
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    K Number
    K040452
    Device Name
    VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
    Manufacturer
    PHARMACIA DEUTSCHLAND GMBH
    Date Cleared
    2004-05-11

    (81 days)

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

    PHARMACIA DEUTSCHLAND GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa B .- Glycoprotein I Antibodies Screen EIA kit is designed for the qualitative determination of B2-Glycoprotein I antibodies in human serum or plasma. The presence of B2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.
    Device Description
    The Varelisa ß2-Glycoprotein I Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against ß glycoprotein I in serum or plasma. The test kit contains microplate strips coated with human purified ß2glycoprotein I. calibrator, negative control, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.
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    K Number
    K020752
    Device Name
    VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
    Manufacturer
    PHARMACIA DEUTSCHLAND GMBH
    Date Cleared
    2002-05-02

    (56 days)

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

    PHARMACIA DEUTSCHLAND GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa Cardiolipin IgG Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgG antibodies against cardiolipin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).
    Device Description
    The Varelisa Cardiolipin IgG Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of IgG antibodies against cardiolipin in human serum or plasma. The wells of a microplate are coated with bovine cardiolipin antigen. Antibodies specific for cardiolipin present in the patient sample bind to the antigen. In a second step an enzyme labeled second antibody (Conjugate) binds to the antigenantibody complex which leads to the formation of an enzyme labeled antigen-antibody sandwich complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution. The rate of color formation from the chromogen is a function of the amount of Conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.
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    K Number
    K020757
    Device Name
    VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
    Manufacturer
    PHARMACIA DEUTSCHLAND GMBH
    Date Cleared
    2002-05-02

    (56 days)

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

    PHARMACIA DEUTSCHLAND GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa Cardiolipin IgA Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgA antibodies against cardiolipin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).
    Device Description
    The Varelisa Cardiolipin IgA Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of IgA antibodies against cardiolipin in human serum or plasma. The wells of a microplate are coated with bovine cardiolipin antigen. Antibodies specific for cardiolipin present in the patient sample bind to the antigen. In a second step an enzyme labeled second antibody (Conjugate) binds to the antigenantibody complex which leads to the formation of an enzyme labeled antigen-antibody sandwich complex. The enzyme labeled antigen-antibody complex converts the added substrate to form a colored solution. The rate of color formation from the chromogen is a function of the amount of Conjugate complexed with the bound antibody and thus is proportional to the initial concentration of the respective antibodies in the patient sample.
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    K Number
    K020758
    Device Name
    VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
    Manufacturer
    PHARMACIA DEUTSCHLAND GMBH
    Date Cleared
    2002-05-02

    (56 days)

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

    PHARMACIA DEUTSCHLAND GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa Cardiolipin IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgM antibodies against cardiolipin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).
    Device Description
    The Varelisa Cardiolipin IgM Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of IgM antibodies against cardiolipin in human serum or plasma. The wells of a microplate are coated with bovine cardiolipin antigen. Antibodies specific for cardiolipin present in the patient sample bind to the antigen. In a second step an enzyme labeled second antibody (Conjugate) binds to the antigenantibody complex which leads to the formation of an enzyme labeled antigen-antibody sandwich complex.
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