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    K Number
    K234091
    Device Name
    Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
    Manufacturer
    Genalyte, Inc.
    Date Cleared
    2024-07-22

    (209 days)

    Product Code
    JLW, JJE
    Regulation Number
    862.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Genalyte, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maverick Test Panel A0.B0 is an immunoassay for the quantitative determination of human thyroid stimulating hormone (thyrotropin, TSH) in human serum and K2EDTA plasma on the Maverick Diagnostic System TC1000. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The Maverick Diagnostic System TC1000 is an automated immunoassay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.
    Device Description
    The Maverick Diagnostic System TC1000 is an automated immunoassay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology. The Maverick Test Panel A0.B0 is an immunoassay for the quantitative determination of human thyroid stimulating hormone (thyrotropin, TSH) in human serum and K2EDTA plasma on the Maverick Diagnostic System TC1000.
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    K Number
    K191085
    Device Name
    Maverick RNP Assay and Maverick Diagnostic System
    Manufacturer
    Genalyte, Inc.
    Date Cleared
    2019-10-25

    (184 days)

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

    Genalyte, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maverick RNP Assay is an immunoassay for the semi-quantitative determination of anti-RNP IgG antibodies in human serum on the Maverick Diagnostic System. The presence of antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Mixed Connective Tissue Disease (MCTD). The Maverick Diagnostic System (MDS) is an automated immunoasay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.
    Device Description
    The Maverick Diagnostic System (MDS) is an automated immunoasay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.
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