Vital Diagnostics

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Web: http://www.vitaldiagnosticsinc.com
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Address: 27 Wellington Road, Lincoln, Rhode Island 02865, USA
Phone: +1-(401)-642-8400, 800-345-2822 | Fax: +1-(401)-642-9001 | Map/Directions >>

Profile: Vital Diagnostics provides products and services for the clinical laboratory in the traditional in-vitro diagnostics. We manufacture and distribute clinical chemistry and hematology analyzers, along with reagents. Our Excyte® Mini analyzer combines all the features needed in an automated erythrocyte sedimentation rate (ESR) analyzer, with the ease-of-use and reliability. With 10 positions and half-hour test time, it performs up to 20 SED rate tests per hour.It has features like random access, and closed tube testing. Our Excyte® 40 combines all the features needed in an automated ESR analyzer, with the high throughput capability needed. With forty positions and 30 minute test time, it performs up to 80 SED rate tests per hour.

The company is ISO 13485:2003, ISO 9001:2000 certified.

42 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).

• 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.

• Automated Sedimentation Rate Device (FDA Code: GKB / 864.5800)

An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a 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.

• Blood Gas and Ph Electrode Measurement (FDA Code: CHL / 862.1120)

A blood gases (PCO2, PO2) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

• 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 Azo-Dye (FDA Code: CJY / 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 Cresolphthalein Complexone Test (FDA Code: CIC / 862.1145)

• Chemistry Analyzers

• Chemistry/Hematology Analyzer

• 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.

• Discrete Photometric Chemistry Analyzer (FDA Code: JJE / 862.2160)

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

• 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.

• ESR Analyzers

• ESR Tubes

• ESR Vaccum Tubes

• Ferrozine Iron Binding Capacity Test (FDA Code: JMO / 862.1415)

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

• 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.

• Glycosylated Hemoglobin Assay Test (FDA Code: LCP / 864.7470)

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

• Hematology Analyzers

• 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.

• Laboratory Hematology Analyzers

• 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.

• Lipoprotein Low-Density Test System (FDA Code: MRR / 862.1475)

• 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).

• Multi Analyte Control (FDA Code: JJY / 862.1660)

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 862.1150)

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)

• 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.

• 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.

• Primary Calibrator (FDA Code: JIS / 862.1150)

• Secondary Calibrator (FDA Code: JIT / 862.1150)

• 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 Urease and Glutamic Dehydrogenase Test (FDA Code: CDQ / 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.