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510(k) Data Aggregation

    K Number
    K181436
    Device Name
    OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
    Manufacturer
    Sekisui Diagnostics, LLC
    Date Cleared
    2018-06-22

    (21 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Product Code :

    KTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSOM® Mono Test is intended for the qualitative detection of infectious monomucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis.
    Device Description
    The OSOM Mono Test uses color immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. In the test procedure, serum, plasma or whole blood is mixed with the Diluent. Then the Test Stick is placed in the mixture migrates along the membrane. If the specific IM heterophile antibody is present in the sample, it will form a complex with the bovine erythrocyte extract conjugated color particles. The complex will then be bound by bovine erythrocyte xtract immobilized on the membrane and a visible blue Test Line will appear to indicate a positive result.
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    K Number
    K042272
    Device Name
    ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
    Manufacturer
    ACON LABORATORIES, INC.
    Date Cleared
    2005-02-28

    (189 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Product Code :

    KTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of heterophile antibodies to infectious Mononucleosis in whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis infection in adults at 18 years of age and older. They are intended for health professionals including professionals at point-of-care sites.
    Device Description
    The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of heterophile antibodies associated with infectious Mononucleosis in whole blood, serum or plasma. They utilize purified IM heterophilic antigen-coated particles and IM heterophilic antigen-coated on the membrane to selectively detect elevated levels of heterophile antibodies to infectious Mononucleosis. These tests can be performed without the use of an instrument.
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    K Number
    K030215
    Device Name
    BIORAPID MONONUCLEOSIS
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2003-02-24

    (34 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Product Code :

    KTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis.
    Device Description
    biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis. biorapid Mononucleosis uses the same methodology (immunochromatography test) as the predicate OSOM Mono Test.
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    K Number
    K012901
    Device Name
    COLOR-MONOGEN
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2001-09-27

    (29 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Product Code :

    KTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma. The test aids in the diagnosis of infectious mononucleosis.
    Device Description
    Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma.
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    K Number
    K982634
    Device Name
    DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1999-01-28

    (184 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Product Code :

    KTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acute infectious mononucleoisis is a self-limiting clinical syndrome that most commonly occurs in teenagers and young adults in developed nations. In developing, IM can occur much earlier in life. This assay is intended for use as an aid in the rapid diagnosis of IM.
    Device Description
    The Dryspot IM Test is a simple two minute latex agglutination test for the detection of the specific heterophile antibody associated with IM in serum and plasma. The purified specific heterophile antigen from bovine red cell membranes is used to coat latex particles. When a drop of serum or plasma containing the heterophile antibody associated with IM is mixed with a drop of latex, visible agglutination of the latex occurs within 2 minutes. Agglutination will not occur when such an antibody is absent.
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    K Number
    K981946
    Device Name
    CLEARVIEW IM
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    1998-12-10

    (190 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Product Code :

    KTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clearview IM is an immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis.
    Device Description
    Not Found
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    K Number
    K972457
    Device Name
    MONOCOL/LEX-IM TEST
    Manufacturer
    IMMUNOSTICS, INC.
    Date Cleared
    1997-12-01

    (153 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Product Code :

    KTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MONOCOL/LEX-IM TEST is a rapid color enhanced latex slide agglutination test for the qualitative and semiquantitative detection of heterophile antibodies in serum or plasma associated with infectious mononucleosis and is to be used as an aid in the diagnosis of infectious mononucleosis. This test is "For Professional Use Only".
    Device Description
    Not Found
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    K Number
    K972231
    Device Name
    OSOM MONO TEST 143
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Date Cleared
    1997-08-26

    (71 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Product Code :

    KTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSOM™ Mono Test is intended for the qualitative determination of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aids in the diagnosis of infectious mononucleosis .
    Device Description
    OSOM Mono Test uses color immunochromatographic technology with bovine erythrocyte extract coated on the membrane. If the specific IM heterophile antibody is present in the sample, a visible blue test line will appear to indicate a positive result.
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    K Number
    K963425
    Device Name
    GENZYME DIAGNOSTICS CONTRAST MONO
    Manufacturer
    GENZYME DIAGNOSTICS
    Date Cleared
    1997-02-25

    (179 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Product Code :

    KTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician's office laboratory and the clinical laboratory.
    Device Description
    Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen using mouse monoclonal anti-IgM antibodies and heterophile antigen from bovine red blood cells.
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    K Number
    K961024
    Device Name
    BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
    Manufacturer
    PRINCETON BIOMEDITECH CORP.
    Date Cleared
    1997-02-04

    (327 days)

    Product Code
    KTN
    Regulation Number
    866.5640
    Why did this record match?
    Product Code :

    KTN

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

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