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510(k) Data Aggregation

    K Number
    K972406
    Device Name
    ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
    Manufacturer
    IMMUNO PROBE, INC.
    Date Cleared
    1997-12-22

    (179 days)

    Product Code
    GOD
    Regulation Number
    866.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMUNO PROBE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Adenovirus Antigen Detection ELISA Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of Adenovirus antigen in human fecal samples as an aid in the diagnosis of acute non-bacterial gastro-enteritis. Performance for this assay has not been established on children over the age of five and immunocompromised patients. The antibody utilized in this assay is a group specific antigen and cannot differentiate between types of adenovirus. Performance of this assay has not been established for specimens other than human feces. For in vitro diagnostic use only.
    Device Description
    The Adenovirus Antigen Detection ELISA test is an enzyme linked immunosorbent assay to detect adenovirus antigen in fecal samples. Purified monoclonal antibody specific to adenovirus is attached to a solid phase microtiter well. Diluted fecal sample is added to each well. If the adenovirus antigen is present, it will bind to the monoclonal antibody in the well. After incubation the wells are washed to remove unbound antigen. An enzyme labeled anti-adenovirus polyclonal antibody is added to each well. If antigen is present the conjugate antibody will bind to the antigen attached to the antibody on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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    K Number
    K971393
    Device Name
    MYCOPLASMA IGG ELISA TEST SYSTEM
    Manufacturer
    IMMUNO PROBE, INC.
    Date Cleared
    1997-07-14

    (96 days)

    Product Code
    LJZ
    Regulation Number
    866.3375
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMUNO PROBE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mycoptasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.
    Device Description
    The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semiquantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For In Vitro Diagnostic Use Only. The Mycoplasma IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Mycoplasma pneumoniae. Purified Mycoplasma pneumoniae antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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    K Number
    K961764
    Device Name
    PR-3 ELISA TEST SYSTEM
    Manufacturer
    IMMUNO PROBE, INC.
    Date Cleared
    1996-08-19

    (104 days)

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

    IMMUNO PROBE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    The PR-3 ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to Proteinase-3 in human sera. The PR-3 ELISA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to Proteinase-3. Purified PR-3 is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG, M, A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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    K Number
    K961765
    Device Name
    MPO ELISA TEST SYSTEM
    Manufacturer
    IMMUNO PROBE, INC.
    Date Cleared
    1996-08-19

    (104 days)

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

    IMMUNO PROBE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    The MPO EIA test is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of antibodies to myeloperoxidase in human sera. The MPO EIA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to myeloperoxidase. Purified MPO is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG. M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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    K Number
    K951549
    Device Name
    EBNA IGG EIA TEST SYSTEM
    Manufacturer
    IMMUNO PROBE, INC.
    Date Cleared
    1996-04-29

    (391 days)

    Product Code
    LLM
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMUNO PROBE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ImmunoProbe anti-EBNA-1 IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA (R&D), and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.
    Device Description
    The Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgG kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the semi-quantitative determination of IgG antibodies in human serum to EBNA-1 antigen. The EBNA-1 IgG EIA test is an enzyme linked immunosorbent assay to detect IgG antibodies to EBNA-1. Purified recombinant EBNA-1 is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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    K Number
    K952521
    Device Name
    CARDIOLIPIN IGM EIA TEST SYSTEM
    Manufacturer
    IMMUNO PROBE, INC.
    Date Cleared
    1996-02-09

    (253 days)

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

    IMMUNO PROBE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K952522
    Device Name
    CARDIOLIPIN IGA EIA TEST SYSTEM
    Manufacturer
    IMMUNO PROBE, INC.
    Date Cleared
    1996-02-09

    (253 days)

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

    IMMUNO PROBE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K952523
    Device Name
    CARDIOLIPIN IGG EIA TEST KIT
    Manufacturer
    IMMUNO PROBE, INC.
    Date Cleared
    1996-02-09

    (253 days)

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

    IMMUNO PROBE, INC.

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

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