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CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2).

CueSee® Hypoxic is prepared from a stroma-free bovine hemoglobin solution and provides the oxygen buffering characteristics of fresh whole blood. The concentrations of total hemoglobin and acid-base levels are within the normal physiological range. Tonometry with a predetermined level of oxygen balanced with nitrogen provides a distinct assay value for partial pressure of oxygen measurements. CueSee® Hypoxic contains no preservatives, viscosity adjusters or other additives that might adversely effect electrode measurements. CueSee® Hypoxic provides one level in the critical low pO2 value range, each ampule holding 2.5 mL of solution. CueSee® Hypoxic is packed in a carton box containing 5 ampules.

This Hematocrit and Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: cGlucose, cLactate, Hct

Hematocrit and Metabolite QUALICHECK is a two-level quality control system consisting of: - Hematocrit and Metabolite QUALICHECK, Level 1 (S7170), 944-039 - Hematocrit and Metabolite QUALICHECK, Level 2 (S7180), 944-040 The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution. The quality control solution is an aqueous solution containing an organic buffer, acid, salts, metabolites, and a preservative.

This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: pO2, ctHb, cGlucose, cLactate

High Metabolite QUALICHECK is a single level quality control system consisting of: High Metabolite QUALICHECK (S7570). The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution. The quality control solution is an aqueous solution containing a biological buffer, salts, metabolites, and a preservative.

For In Vitro Diagnostic Use. This Range+ QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges.

Range+ QUALICHECK is a three level quality control system consisting of: - Range+ QUALICHECK, LEVEL 1 (S7930) . - Range+ QUALICHECK, LEVEL 2 (S7940) . - Range+ QUALICHECK, LEVEL 3 (S7950) . Each level consists of 30 ampoules per box. One ampoule contains 2 mL of solution. The quality control solution is an aqueous solution containing a biological buffer, salts, glucose, lactate, dyes and a preservative, and it is equilibrated with carbon dioxide and oxygen.

Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation. There are 4 levels of QC encompassed in this request. Levels 1,2,3 cover the Low Mid High of the clinical range for the analytes included in the QC. Level 4 is to check at High O2 level. Mission Controls are intended for six systems: AVL Scientific, Ciba-Coming/Bayer, IL, NOVA, Radiometer, Medica, Shapparelli, Medarini. The products encompassed by this request are intended for in-vitro diagnostics use and are intended for pH/Blood Gas = (pr). pCO2, pO2), and Licolorito - (No, N, Ol, St, L. ( St, S.) = S. ( = ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.

Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test . imprecision and to detect systematic deviations that may occur because of instrument or reagent variation. Mission Controls are aqueous based tonometered controls . Mission uses a similar composition, description and packaging as that used by the predicate Mission uses a similar oompoomon, assistion of this submission.

Liquichek™ Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) is an assayed quality control intended for use in monitoring the precision of an individual laboratory's measurement of pH, pCO2, pO2, electrolytes, glucose, lactate (lactic acid), total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and Radiometer 700 Series CO-Oximetry instrumentation.

Liquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series) is a dye based, buffered bicarbonate and electrolyte solution in equilibrium with pre-determined levels of oxygen, carbon dioxide, nitrogen, glucose and lactate (lactic acid).

Liquichek™ Blood Gas Plus Co-Oximeter Control (IL Synthesis Series) is an assayed quality control intended for use in monitoring the precision of an individual laboratory's measurement of pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis Co-Oximetry instrumentation.

Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) is a dye based, buffered bicarbonate and electrolyte solution in equilibrium with pre-determined levels of oxygen, carbon dioxide, nitrogen and glucose.