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Genchem, Inc.


Web: http://www.genchem.org
Address: 32756 Cameron, Dana Point, California, USA
Phone: +1-(714)-256-4910 | Fax: +1-(714)-256-1971 | Map/Directions >>
 
 

Profile: Genchem, Inc. develops, manufactures and sells diagnostic chemistry reagents to hospital, commercial & physician laboratories. We develop diagnostic products utilized in the diagnosis of disease states.

FDA Registration Number: 3005432203

32 Products/Services (Click for related suppliers)  
• Alkaline Picrate Creatinine Colorimetric Method (FDA Code: CGX / 862.1225)
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. 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.
• Amylase Catalytic Method Test (FDA Code: JFJ / 862.1070)
An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
• Amylase Saccharogenic Test (FDA Code: CIJ / 862.1070)
• Ast/Sgot Nadh Oxidation/Nad Reduction (FDA Code: CIT / 862.1100)
An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
• Bilirubin Diazo Colorimetry Test (FDA Code: CIG / 862.1110)
A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
• Bromcresol Green Dye-Binding, Albumin (FDA Code: CIX / 862.1035)
An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
• Calcium Cresolphthalein Complexone Test (FDA Code: CIC / 862.1145)
A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
• Calcium Ion Specific Electrode (FDA Code: JFP / 862.1145)
• Carbon-Dioxide pH Rate Measurement Test (FDA Code: JFL / 862.1160)
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
• Chloride Ion Specific Electrode (FDA Code: CGZ / 862.1170)
A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
• Colorimetric Uric Acid Test (FDA Code: KNK / 862.1775)
A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
• Diagnostic Products
• Enzymatic Esterase-Oxidase, Cholesterol (FDA Code: CHH / 862.1175)
A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
• Gamma-Glutamyl Transpeptidase Kinetic Method (FDA Code: JQB / 862.1360)
A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
• Glucose Hexokinase Test (FDA Code: CFR / 862.1345)
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• Glucose Oxidase, Glucose (FDA Code: CGA / 862.1345)
• Inorganic Phosphorus Phosphomolybdate (FDA Code: CEO / 862.1580)
A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
• Iron Photometric Method (FDA Code: JIY / 862.1410)
An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
• Isoenzymes NAD Reduction/NADH Oxidation (FDA Code: CGS / 862.1215)
A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
• Lactate Dehydrogenase NAD Reduction/NADH Oxidation (FDA Code: CFJ / 862.1440)
A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
• LDL & VLDL Precipitation, Cholesterol Via Esterase-Oxidase (FDA Code: LBS / 862.1475)
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
• Magnesium Photometric Method Test (FDA Code: JGJ / 862.1495)
A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
• Nadh Oxidation/Nad Reduction (FDA Code: CKA / 862.1030)
An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
• Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE / 862.1050)
An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
• Piston Syringe (FDA Code: FMF / 880.5860)
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
• Potassium Ion Specific Electrode (FDA Code: CEM / 862.1600)
A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
• Purple Bromcresol Albumin Dye-Binding Test (FDA Code: CJW / 862.1035)
• Sodium Ion Specific Electrode (FDA Code: JGS / 862.1665)
A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device 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 antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
• Total Protein Biuret Method (FDA Code: CEK / 862.1635)
A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
• Triglycerides Lipase Hydrolysis/Glycerol Kinase Enzyme Test (FDA Code: CDT / 862.1705)
A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
• Urea Nitrogen Ion Specific Electrode (FDA Code: CDS / 862.1770)
A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
• Urea Nitrogen Urease and Glutamic Dehydrogenase Test (FDA Code: CDQ / 862.1770)

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