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510(k) Data Aggregation

    K Number
    K081938
    Device Name
    ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
    Manufacturer
    GENZYME DIAGNOSTICS P.E.I. INC.
    Date Cleared
    2009-05-01

    (297 days)

    Product Code
    LDP
    Regulation Number
    862.3030
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    Applicant Name (Manufacturer) :

    GENZYME DIAGNOSTICS P

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.
    Device Description
    For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.
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    K Number
    K082210
    Device Name
    TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
    Manufacturer
    GENZYME DIAGNOSTICS P.E.I. INC.
    Date Cleared
    2008-12-16

    (132 days)

    Product Code
    CIG
    Regulation Number
    862.1110
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    Applicant Name (Manufacturer) :

    GENZYME DIAGNOSTICS P

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the IN VITRO quantitative measurement of Total Bilirubin in serum and plasma. Measurement of Total Bilirubin is used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases and disorders involving the metabolism of bilirubin.
    Device Description
    Not Found
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    K Number
    K043385
    Device Name
    OSOM HCG COMBO TEST
    Manufacturer
    GENZYME DIAGNOSTICS
    Date Cleared
    2005-04-12

    (124 days)

    Product Code
    JHI
    Regulation Number
    862.1155
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    Applicant Name (Manufacturer) :

    GENZYME DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.
    Device Description
    The OSOM hCG Combo device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume Pipette provided. The sample migrates through reaction pads where hCG, if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled hCG complex is captured at a test line region containing immobilized rabbit anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it). The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.
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    K Number
    K983399
    Device Name
    GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
    Manufacturer
    GENZYME DIAGNOSTICS
    Date Cleared
    1999-01-11

    (105 days)

    Product Code
    MHI
    Regulation Number
    866.3220
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    Applicant Name (Manufacturer) :

    GENZYME DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is an immunochromatographic assay for the simultaneous qualitative detection and distinguishing of Giardia and Cryptosporidium specific antigens in aqueous extracts of fecal specimens. It is intended for professional laboratory use. For In Vitro Diagnostic Use.
    Device Description
    Immunoassay for Giardia and Cryptosporidium Antigens
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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
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    Applicant Name (Manufacturer) :

    GENZYME DIAGNOSTICS

    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
    K964155
    Device Name
    CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST
    Manufacturer
    GENZYME DIAGNOSTICS
    Date Cleared
    1996-11-25

    (40 days)

    Product Code
    JHI
    Regulation Number
    862.1155
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    Applicant Name (Manufacturer) :

    GENZYME DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy for use in the physician's office and clinical laboratories.
    Device Description
    Rapid membrane based immunoassay for the qualitative detection of hCG using mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies.
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    K Number
    K964156
    Device Name
    CONTRAST STRIP HCG
    Manufacturer
    GENZYME DIAGNOSTICS
    Date Cleared
    1996-11-25

    (40 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENZYME DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy in physician's office and clinical laboratories. The intended use of the Genzyme Diagnostics Contrast® Strip hCG is the early determination of pregnancy by the qualitative detection of human chorionic gonadotropin (hCG) in human serum or urine. Our intent is to market this product for laboratory and professional use.
    Device Description
    Rapid membrane based immunoassay for the qualitative detection of hCG using mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies.
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