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510(k) Data Aggregation

    K Number
    K202826
    Device Name
    IMMULITE® 2000 Cortisol
    Manufacturer
    Siemens Healthcare Diagnostics Products Ltd.
    Date Cleared
    2021-01-15

    (113 days)

    Product Code
    CGR
    Regulation Number
    862.1205
    Why did this record match?
    Applicant Name (Manufacturer) :

    Siemens Healthcare Diagnostics Products Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the quantitative measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
    Device Description
    The IMMULITE 2000 Cortisol assay is comprised of the following components: Cortisol Bead Pack (solid phase) containing Polyclonal rabbit anti-cortisol antibody; Cortisol Reagent Wedge (liquid phase) containing Alkaline phosphatase (bovine calf intestine) conjugated to cortisol in buffer, with preservative; and Cortisol Adjustors (Low and High) containing Cortisol in processed human serum, with preservative.
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    K Number
    K203270
    Device Name
    IMMULITE/IMMULITE® 1000 Cortisol
    Manufacturer
    Siemens Healthcare Diagnostics Products Ltd.
    Date Cleared
    2021-01-15

    (71 days)

    Product Code
    CGR
    Regulation Number
    862.1205
    Why did this record match?
    Applicant Name (Manufacturer) :

    Siemens Healthcare Diagnostics Products Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use with the IMMULITE® and IMMULITE 1000 Analyzers - for the quantitative measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
    Device Description
    The IMMULITE/IMMULITE® 1000 Cortisol assay is comprised of the following components: Cortisol Test Unit (solid phase) - 1 bead/Test unit, Polyclonal rabbit anti-cortisol antibody. Cortisol Reagent Wedge (liquid phase) - 7.5 mL, Alkaline phosphatase (bovine calf intestine) conjugated to cortisol in buffer, with preservative. Cortisol Adjustors (Low and High) - 3 mL, Cortisol in processed human serum, with preservative.
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