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The ELITech Clinical system Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophotometric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidimetric assays. The second module is an electrometer used for measurement of electrolytes. For in vitro diagnostic use only. ELITech Clinical Systems AST/GOT 4+1 SL is a reagent for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate Amino Transferase (AST) in human serum and plasma on ELITech Clinical Systems Selectra ProM analyzer. Aspartate Amino Transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the ELITech Clinical Systems Selectra ProM analyzers. ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in accuracy and precision of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module. ELITech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), and chloride (Cl-) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module. ISE Sodium Electrode: The sodium electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of sodium in serum and plasma. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine accompanied by extreme thirst), adrenal hypertension. Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate anticluretic hormone secretion or other diseases involving electrolyte imbalance. ISE Potassium Electrode: The potassium electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of potassium in serum and plasma. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. ISE Chloride Electrode: The Chloride electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of chloride in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Selectra ProM is an automated, in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically: the analyzer also has an ISE module for measuring sodium, potassium and chloride electrometrically. The Selectra ProM instrument is a random access analyzer designed to be operated on a bench top in the professional environment using a combination of a photometric analysis unit and an ion selective electrodes (ISE). AST/GOT 4+1 SL is available as kit only. It consists of 2 reagents: Reagent 1 contains Tris buffer. L-Aspartate; Lactate dehydrogenase (LDH) (microorganisms), Malate dehydrogenase (MDH) (bacterial) and sodium azide. Reagent 2 contains α-Ketoglutarate, NADH and sodium azide. The Sodium, Potassium and Chloride ISE Electrodes are comprised of the electrodes plus ISE Reference Solution, ISE Diluent, ISE Calibrators. ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A. ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HV according to FDA-approved methods in compliance with the European Directive 98/79/EC, Annex II, List A.