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The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use. ELITech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart disease. ELITech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL I is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.

The reagent device for this submission 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 alpha-Ketoglutarate, NADH and sodium azide The Vital Scientific Selectra Junior is a benchtop discrete chemistry photometric analyzer for in vitro diagnostic use. 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 FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A. ELITech Clinical Systems 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 HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease. For in vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a calibrator for the DiaSys ASAT (GOT) FS assay. For in vitro diagnostic use for quantitative testing on the Hitachi 917 instrument. TruLab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.

The DiaSys ASAT (GOT) FS assay is based on NADH reduction to NAD, as shown in the following equation: L-Aspartate + 2-Oxoglutarate <ASAT> L-Glutamate + Oxalacetate Oxalacetate + NADH + H' < MDH > L-Malate + NAD* Addition of pyridoxal-5-phosphate (P-5-P) stabilizes the transaminases and avoids falsely low values in samples containing insufficient endogenous P-5-P, e.g. from patients with myocardial infarction, liver disease and intensive care patients . TraCal U calibrator-Serum based calibrator for use in the calibration of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917. Trulab N and TruLab P controls-Serum based control serum in normal and pathological range for use in quality control for monitoring accuracy and precision of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.

Activated Aspartate Aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Abbott Laboratories Activated AST is an in vitro diagnostic assay for the quantitation of aspartate aminotransferase (also known as serum glutamic oxaloacetic transferase or SGOT) in human serum or plasma. The Abbott Laboratories Activated AST assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transfer of the amino group from L-aspartate to a-ketoglutarate, in the presence of pyridoxal-5'phosphate, forming oxaloacetate and L-glutamate. Oxaloacetate in the presence of NADH and malate dehydrogenase (MDH) is reduced to L-malate. In this reaction, the NADH is concomitantly oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.

The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease. Auxiliary product: Pyridoxal Phosphate Auxiliary reagent for in vitro diagnostic use in the quantitative determination of ALT (GPT) and AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument. For eCal Calibrator, Nortrol and Abtrol see intended use.

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cobas c 111 analyzer: The Roche cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests for professional settings and small laboratories, specialized testing and CLIA-licensed doctor's offices. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. Reagents: Aspartate aminotransferase (ASTL/ASTPL) In vitro test for the quantitative determination of AST in human serum and plasma on the cobas c1 11 system. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. C-Reactive Protein Latex (CRPLX) In vitro test for the quantitative immunological determination of human C-reactive protein in human serum and plasma on the cobas c111 system. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. Glucose HK (GLUC2) In vitro test for the quantitative determination of glucose concentration in human serum and plasma on the cobas c111 system. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia. ISE Chloride Electrode The chloride electrode for the cobas c111 system is intended for the quantitative determination of chloride in diluted serum, plasma, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. ISE Potassium Electrode The potassium electrode for the cobas c111 system is intended for the quantitative determination of potassium in diluted serum, plasma, and urine. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. ISE Sodium Electrode The sodium electrode for the cobas c111 system is intended for the quantitative determination of sodium in diluted serum, plasma, and urine. Measurements of sodium are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insibidus (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 antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The Roche cobas c 111 analyzer is an 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 optional ISE module for measuring sodium, potassium and chloride.

Hepatic Enzymes reagents, with associated calibrators and controls, are intended for Hopano Enlighted Chemistry Analyzer to measure a variety of analytes. ABX PENTRA AST CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer. The ABX PENTRA 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module). All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters

The WIENER LAB. GOT (AST) UV AA Líquida test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma on both manual and automated systems. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

Kinetic Method. The principle is based on the following reaction system: GOT (AST) L-aspartate + 2-oxoglutarate → Oxaloacetate + L-glutamate MDH Oxalacetate + NADH + H + → L-Malate + NAD + The rate of disappearance of NADH and the resulting decrease in absorbance at 340 nm is directly proportional to the activity of GOT (AST). AST or GOT: Aspartate Aminotransferase. MDH: Malate Dehydrogenase. NADH: Nicotinamide-Adenine Dinucleotide (Reduced) NAD + : Nicotinamide-Adenine Dinucleotide. H + : Proton.

Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

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The WIENER LAB GOT (AST) UV test system is an I.V.D. device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

The principle is based on the following reaction system: GOT L-aspartate + 2-oxoglutarate -> oxaloacetate + L-glutamate MDH Oxalacetate + NADH + H+ -> I-Malate + NAD+ AST or GOT: Aspartate Amino transferase MDH: Malate Dehydrogenase