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510(k) Data Aggregation

    K Number
    K053571
    Device Name
    MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    Manufacturer
    INTERLAB S.R.L.
    Date Cleared
    2006-06-30

    (190 days)

    Product Code
    JBD
    Regulation Number
    864.7440
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERLAB S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microgel Alkaline Hemoglobin Electrophoresis test kit is intended for qualitative and semiquantitative determination of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using agarose gel. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglish hemoglobin electrophoresis is necessary. The electrophoretic test is performed at allialine pH and provides a valuable screening method for hemoglobin patterns. Densitometry of the pattern allows the relative quantification of hemogram patism belief allows the pattern allows the relative automated Microod instrument automated Microgel instrument. The Microgel Acid Hemoglobin Electrophoresis kit is a qualitative test for the identification of both normal and abnomal or variant hemoglobins, and to confirm the identify of clinication of hemoglobins such as A. E. Gand O. Th hemoglobins such as A, F, S and C. The Acid Hemoglobin test kit employs agarose gel at acidic pH and is for in vitro diagnes and of The Rold Hemoglouin test Kit Employs agarose gel at acidid Microgel instrument Microgel instrument.
    Device Description
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    K Number
    K040146
    Device Name
    INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    Manufacturer
    INTERLAB S.R.L.
    Date Cleared
    2004-05-04

    (103 days)

    Product Code
    GKA
    Regulation Number
    864.7415
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERLAB S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Interlab Acid Hemoglobin Electrophoresis is a qualitative test system intended for the electrophoretic separation of hemoglobins to confirm the identity of clinically relevant hemoglobins such as A, F, S and C. It is to be used in conjunction with the Interlab Alkaline Hemoglobin Electrophoresis test kit. The Acid Hemoglobin test kit employs cellulose acetate supported on Mylar® as the medium and is for in vitro diagnostic use. The test can be automated on the Microtech 672 PC and Microtech 648 ISO instruments.
    Device Description
    The InterLab Acid Hemoglobin test kits for the electrophoretic separation of hemoglobin in whole blood and are intended for In-Vitro diagnostic use only. The InterLab Acid Hemoglobin Electrophoresis Test Devices provide qualitative identification of abnormal hemoglobin bands visualized by staining of the fractions. The principle of hemoglobin electrophoresis is based upon the visualization of specific hemoglobin bands following separation by electrophoresis. Dilutions of a patient's specimen are placed on separate tracks (fingers) on a cellulose acetate slide six fingers shaped, and the major hemoglobin groups are separated by electrophoresis. The migration rate depends on the temperature, pH, ionic force of the solution and proportions of the reactants. After electrophoresis, the slide is processed to remove excess soluble materials through a washing step. Fractionated hemoglobins are stained. The excess of stain is removed by a destaining step. The slides visually read to identify the bands present.
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    K Number
    K032862
    Device Name
    INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    Manufacturer
    INTERLAB S.R.L.
    Date Cleared
    2004-02-03

    (144 days)

    Product Code
    JBD
    Regulation Number
    864.7440
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERLAB S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Interlab Alkaline Hemoglobin Electrophoresis test system is intended for the separation of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using cellulose acetate supported on Mylar®. The test is a screening method for in vitro diagnostic use on the Microtech 672 PC and the Microtech 648 ISO fully automated analyzers. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglobin electrophoresis is necessary.
    Device Description
    The InterLab Hemoglobin devices test kits for the electrophoretic separation of hemoglobin in whole blood and are intended for In-Vitro diagnostic use only. The InterLab Alkaline Hemoglobin Electrophoresis Test Devices provide semi-quantitative identification of hemoglobin bands visualized by staining of the fractions. The principle of hemoglobin electrophoresis is based upon the visualization of specific hemoglobin bands following separation by electrophoresis. Dilutions of a patient's specimen are placed on separate tracks (fingers) on a cellulose acetate slide six fingers shaped, and the major hemoglobin groups are separated by electrophoresis. The migration rate depends on the temperature, pH, ionic force of the solution and proportions of the reactants. After electrophoresis, the slide is processed to remove excess soluble materials through a washing step. Fractionated hemoglobins are stained. The excess of stain is removed by a destaining step.
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    K Number
    K033187
    Device Name
    INTERLAB IMMUNOFIXATION TEST(S)
    Manufacturer
    INTERLAB S.R.L.
    Date Cleared
    2003-11-19

    (49 days)

    Product Code
    CFF, JKM
    Regulation Number
    866.5510
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERLAB S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interlab Immunofixation Electrophoresis Test is for the qualitative in vitro diagnostic separation and identification of abnormal immunoglobulins (IgG, IgM, IgA) and kappa and lambda light chains in human serum and concentrated urine using cellulose acetate supported on Mylar® for the Microtech 672 PC and IFX 600 instruments. This test is useful as an aid in identifying suspected monoclonal gammopathies.
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