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510(k) Data Aggregation
K Number
K202826Device Name
IMMULITE® 2000 Cortisol
Manufacturer
Siemens Healthcare Diagnostics Products Ltd.
Date Cleared
2021-01-15
(113 days)
Product Code
CGR
Regulation Number
862.1205Why 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
K203270Device Name
IMMULITE/IMMULITE® 1000 Cortisol
Manufacturer
Siemens Healthcare Diagnostics Products Ltd.
Date Cleared
2021-01-15
(71 days)
Product Code
CGR
Regulation Number
862.1205Why 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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