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510(k) Data Aggregation

    K Number
    K003054
    Device Name
    AUTOSTAT II ENA-6 PROFILE ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    2000-10-13

    (11 days)

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

    COGENT DIAGNOTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003057
    Device Name
    AUTOSTAT II ENA-4 PROFILE ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    2000-10-13

    (11 days)

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

    COGENT DIAGNOTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002215
    Device Name
    AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    2000-09-28

    (66 days)

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

    COGENT DIAGNOTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993557
    Device Name
    AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    2000-03-03

    (135 days)

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

    COGENT DIAGNOTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum. Uses: The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay may be used on the Hycor Hy. Tec Automated EIA instrument. For in vitro diagnostic use only.
    Device Description
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    K Number
    K994338
    Device Name
    AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    2000-02-03

    (42 days)

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

    COGENT DIAGNOTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENZAME LINKED IMMUNDSOKERAT ASSIM METHOD FOR THE SOMI - QUATITATUE DEFERENTIAN ATTON OF SFECIFIC IGM RHEUMATOLD FACTOR (RF) ANTIES DIES IN HUMAN SEBENA. USES: THE RESULTS OF THE REIGM ASSAY CAN BE USED AS AN AID IN THE DIRENCES & RHERMATORD ARTHRITIS CRA) WHEN SUPPORTED BY OTHER CABORATORY AND CUMCAL INVESTIGATIONS . LEVELS OF THESE AUTOANTIES ARE ONE ONE MINICATION IN A MUTIFACTORIAL DIAGNOSTIC GIME. THE ASSAY MAT BE USED ON THE HAUSE HYOTEC AUTOMATED EIA INSTRUMENT. FOR IN UTRO DIAGNOSIAC USE CAULY
    Device Description
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    K Number
    K993085
    Device Name
    AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    2000-02-01

    (139 days)

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

    COGENT DIAGNOTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enzyme linked immunosorbent assay method for the detection of IgG, IgM and IgA autoantibodies to cardiolipin in human serum. Uses: The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay may be used on the Hycor Hy•Tec Automated EIA instrument. For in vitro diagnostic use only.
    Device Description
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    K Number
    K993304
    Device Name
    AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    1999-12-06

    (63 days)

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

    COGENT DIAGNOTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG rheumatoid factor (RF) antibodies in human serum. Uses: The results of the RF IgG assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay may be used on the Hycor Hy•Tec Automated EIA instrument. For in vitro diagnostic use only.
    Device Description
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    K Number
    K992449
    Device Name
    AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    1999-11-24

    (125 days)

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

    COGENT DIAGNOTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgM autoantibodies to cardiolipin in human serum. Uses: The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-cardiolipin antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay may be used on the Hycor Hy•Tec Automated EIA instrument. For in vitro diagnostic use only.
    Device Description
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    K Number
    K993086
    Device Name
    AUTOSTAT II ANTI-GLIADIN IGA ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    1999-11-12

    (58 days)

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

    COGENT DIAGNOTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to gliadin in human serum. Uses: The results of the anti-gliadin IgA assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-gliadin antibodies including Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay may be used on the Hycor Hy•Tec Automated EIA instrument. For in vitro diagnostic use only.
    Device Description
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    K Number
    K993087
    Device Name
    AUTOSTAT II ANTI-GLIADIN IGG ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    1999-11-12

    (58 days)

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

    COGENT DIAGNOTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to gliadin in human serum. Uses: The results of the anti-gliadin IgG assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-gliadin antibodies including Coeliac Disease. Levels of these antibodies are one indicator in a multi-factorial diagnostic regime. The assay may be used on the Hycor Hy•Tec Automated EIA instrument. For in vitro diagnostic use only.
    Device Description
    Not Found
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