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For the quantitative determination of cortisol in serum using the Ciba Corning Automated Chemiluminescence Systems.

The Ciba Corning ACS Cortisol assay is a competitive chemiluminescent immunoassay. Cortisol in the patient sample competes with the acridinium ester (AE-labeled cortisol (Lite Reagent) for binding to polyclonal rabbit anti-cortisol antibody on the Solid Phase. The polyclonal rabbit anti-cortisol antibody is bound to monoclonal mouse anti-rabbit antibody, which is coupled to paramagnetic particles (solid phase). An inverse relationship exists between the amount of cortisol present in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.

The intended use of Ciba Corning Ciba Corning ACS:180 DPD Assay is for the quantitative of deoxypyridinoline (DPD) in urine using the Ciba Corning ACS:180 automated chemiluminescence systems

The Ciba Corning ACS:180 DPD assay is a competitive immunoassay using direct, competitive chemiluminescent technology. DPD in the patient sample competes with pvridinoline bound to the paramagnetic particles in the Solid Phase for a limited amount of monoclonal mouse anti-DPD antibody in the Lite Reagent. The monoclonal mouse anti-DPD is bound to goat antibody labeled with acridinium ester. An inverse relationship exists between the amount of DPD present in the sample and the amount of relative light units (RLUs) detected by the system.

The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers.

The Chiron Certain Hct is a bi-level quality control material uniquely formulated to provide quality control values for hematocrit analyzers. There are two levels of Certain Hct each provided in 2.5 mL ampules. The product allows verfication of analyzer hematocrit performance within established ranges. Chiron Calibration Vefication Material (CVM™) is formulated to verify the calibration of hematocrit analyzers. The product contains four levels of 2.5 mL ampules and is intended to assist laboratories in compliance with the requirements of calibration verification under CLIA.

The Ciba Corning 400 System is intended for the point-of-care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.

The 400 Series system analyzer is a point of care and laboratory testing analyzer used to for the direct measure of whole blood samples for the determination of the following parameters: - partial pressures of carbon dioxide; pCO2 - partial pressure of oxygen pO2 - pH - sodium; Na* - potassium: K* - ionized calcium; Ca** - chloride: Cli - alucose - hematocrit: Hct

The Ciba Corning 348 System is intended for the point-of-care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.

The 348 Series system analyzer is a point of care and laboratory testing analyzer used for the direct measure of whole blood samples for the determination of the following parameters: - partial pressures of carbon dioxide; pCO2 . - partial pressure of oxygen pO2 . - pH - sodium; Na* . - potassium; K* ● - ionized calcium; Ca** ● - . hematocrit: Hct

The intended use of ACS LH2 is for the quantitative determination of LH in serum using the Ciba Corning Automated Chemiluminescence Systems.

The Ciba Corning ASC LH2 assay is a two-site chemilumometric (sandwhich) assay which uses constant amounts of two antibodies that have specificity for the intact LH molecule. The first antibody or Lite Reagent is a monoclonal mouse anti-LH antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-LH antibody covalently coupled to paramagnetic particles. A direct relationship exists between the LH in a sample and the relative light units (RLUs) detected by the ACS:180 systems.

The intended use of ACS CKMB II is for the quantitative determination of CK-MB (CK-2) in serum or plasma using the Ciba Corning Automated Chemiluminescence Systems.

The Ciba Corning ACS CKMB II assay is a two-site chemilumometric (sandwhich) assay. which uses constant amounts of two antibodies. The first antibody or Lite Reagent is a monoclonal mouse anti-CK-MB antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-CK-BB antibody covalently coupled to paramagnetic particles. A direct relationship exists between the CK-MB in a sample and the relative light units (RLUs) detected by the ACS:180 systems. The assay is unaffected by increased levels of other CK isoenzymes.

For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems.

The Ciba Corning ASC FrT4 Immunoassay is a competitive immunoassay. FT4 in the-sample competes with the acridinium ester (AE-labeled T4 (Lite Reagent) for a limited amount of polyclonal rabbit anti-T4 antibody, which is covalently coupled to paramagnetic particles (solid phase). An indirect relationship exists between the FT4 in a sample and the relative light units (RLUs) detected.