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510(k) Data Aggregation

    K Number
    K093101
    Device Name
    MAGO 4S
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2011-01-21

    (477 days)

    Product Code
    LFX
    Regulation Number
    866.3510
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAMEDIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella. The Mago 4S Automated EIA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.
    Device Description
    The MAGO 4S is an automated laboratory instrument designed to automate the processing of enzyme-linked immunoabsorbent assays (EIA) as well as Immunofluorescence Assay (IFA) slides. The MAGO 4S is designed to minimize manual operations associated with performing routine laboratory analysis by mechanizing and computerizing the test process.
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    K Number
    K021394
    Device Name
    DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2002-07-09

    (68 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAMEDIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative detection of RF IgM-class antibodies in human serum by indirect enzyme immunoassayas an aid in the diagnosis of rheumatoid arthritis (RA). This test kit can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
    Device Description
    The Is-Rheumatoid Factor Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of RF IgM-class in human serum.
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    K Number
    K013956
    Device Name
    DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2002-01-08

    (39 days)

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

    DIAMEDIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamedix Is anti-β,Glycoprotein I Screen Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to ß, glycoprotein I in human serum as an aid in the diagnosis of certain autoimmune thrombotic disorders in patients with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
    Device Description
    The Is anti B, Glycoprotein I Screen Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to ß, glycoprotein I in human serum
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    K Number
    K013628
    Device Name
    DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2001-12-21

    (46 days)

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

    DIAMEDIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamedix Is anti-β ,Glycoprotein | IgG/IgM Test Kit is indications for OSS inmunoassay (EIA) for the semi-quantitative measurement of IgG or IgM antibodies to ßglycoprotein I in human serum as an aid in the diagnosis of certain autoimmune disease thrombotic disorders in patlents with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
    Device Description
    The Is anti-β, Glycoprotein I IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to ß, glycoprotein in human serum
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    K Number
    K012449
    Device Name
    DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2001-10-26

    (86 days)

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

    DIAMEDIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamedix Is anti-Cardiolipin IgG/IgM Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. The assay can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
    Device Description
    The Is anti-Cardiolipin IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum
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    K Number
    K012450
    Device Name
    DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2001-10-26

    (86 days)

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

    DIAMEDIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamedix Is anti-Cardiolipin IgA Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgA antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. The assay can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
    Device Description
    The Is anti-Cardiolipin IgA Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgA antibodies to cardiolipin in human serum
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    K Number
    K012795
    Device Name
    DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2001-09-28

    (38 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAMEDIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamedix Is anti-Gliadin IgG Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG antibodies to gliadin in human serum as an aid in the diagnosis of celiac disease. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
    Device Description
    The Is-anti-Gliadin IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG antibodies to gliadin in human serum.
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    K Number
    K012797
    Device Name
    DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2001-09-28

    (38 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAMEDIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamedix Is anti-Gliadin IgA Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgA antibodies to gliadin in human serum as an aid in the diagnosis of celiac disease. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor
    Device Description
    The Is anti-Gliadin IgA Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgA antibodies to gliadin in human serum
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    K Number
    K012053
    Device Name
    DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2001-08-20

    (49 days)

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

    DIAMEDIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamedix Is anti-Cardiolipin Screen Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor
    Device Description
    The Is anti-Cardiolipin Screen Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to cardiolipin in human serum
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    K Number
    K002262
    Device Name
    DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2000-11-28

    (126 days)

    Product Code
    LGC
    Regulation Number
    866.3305
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAMEDIX CORP.

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

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