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The Nova StatSensor Creatinine Hospital Meter System consists of the StatSensor Creatinine Hospital Meter and the Stat-Sensor Creatinine Test Strips. The Nova StatSensor Creatinine Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary. venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.

The Nova StatSensor Creatinine Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The Nova StatSensor Creatinine Hospital Meter System is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical creatinine electrochemical test strips to measure creatinine in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring creatinine, the meter stores patient test data, QC test data, and other information relating to patient sample, operator, reagents, and the meter. A user interface provides a self-prompting environment via a color LCD. The Charging Station recharges the batteries of the meter.

The Chloride test, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. Chloride measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of electrolyte and metabolic disorders. The Creatinine test, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal diseases and in monitoring renal dialysis.

The epoc Blood Analysis System is an in vitro analytical system comprising a network of one or more epoc Readers designed to be used at the point of care (POC). The readers accept an epoc single use test card containing a group of sensors that perform diagnostic testing on whole blood. The blood test results are transmitted wirelessly to an epoc Host, which displays and stores the test results. The epoc System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of whole blood. The test card panel configuration currently includes sensors for Sodium Na, Potassium K, Ionized Calcium iCa, pH, pCO2, pO2, Lactate, Glucose and Hematocrit Hct. This submission adds Chloride and Creatinine to this list of approved tests.

The Nova StatSensor Creatinine Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates. Nova StatSensor Creatinine Test Strips are intended for use only with the StatSensor Creatinine Hospital Meter for quantitative tests. The Nova StatSensor Creatinine Hospital Meter is intended to quantitatively measure creatinine in whole blood. The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatSensor Creatinine Test Strips are for testing outside the body (in vitro diagnostic use only). Nova StatSensor Creatinine Control Solutions are intended for use with the Nova StatSensor Creatinine Hospital Meter and Nova StatSensor Creatinine Test Strips as a quality control check to verify the accuracy of blood creatinine test results. There are three levels of controls, (Level 1, Level 2, and Level 3). These solutions will be offered for sale separately from the meter. Nova StatSensor Creatinine Linearity Kit solutions are used to check the linearity of the Nova StatSensor Creatinine Hospital Meter System. There are five levels of Linearity Solutions, (Level 1, Level 2, Level 3, Level 4, and Level 5).

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The ABL837 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood, plasma and serum for the parameter Creatinine measurements measurements measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

The ABL837 FLEX is an analyzer with the capability of measuring creatinine. The wet section of the ABL837 FLEX analyzer is structured as the wet section of the ABL800 FLEX and ABL800 FLEX with FLEXQ Module analyzers, but includes a measuring module comprising the measurement system for the creatinine parameter. This measuring system compissing electrodes, one of which measures creatine and the other of which measures creating and creatinine. The creatinine parameter value is determined as a difference measure of the output of these two new electrodes. The two electrodes are developed based on the concept of the existing Radiometer Medical ApS glucose and lactate electrodes. The sensors for measuring creatinine are electrochemical sensors.

The Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage in the quantitative determination of sodium, potassium, chloride, ionized calcium, creatinine, glucose, lactate, and BUN in serum, plasma and whole blood.; of pH, PCO2, PO2, oxygen saturation, hematocrit and hemoglobin in whole blood.

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For the quantitative determination of Creatinine (Crea) in whole blood with the i-STAT analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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