Profile: Wiener Laboratorios SAIC offers products focused on clinical and specialized laboratories as well as blood banks. Our varied range of products comprises kits & analyzers for clinical chemistry, hematology, coagulation and immunology assays. Our Wiener lab Col 1 is a compact one-channel analyzer whose principle of measurement is turbodensitometry. When the starter reagent is added, and as the clot is formed, the passage of light begins to decrease. A small steel cylinder is magnetically stirred inside the cuvette in order to keep the particulate reagents in suspension. At a certain level, the reaction stops and the instrument informs & prints the obtained values. The different functions are selected on the liquid crystal screen. Our Stat Fax 2100/Wiener Reader 2000 is a highly versatile software that uses pre-programmed techniques, which makes it possible to obtain results with no need of complementary calculations. It is used for qualitative and quantitative tests in microplate ELISA techniques.

The company has revenues of USD 10-25 Million, has ~150 employees and is ISO 9001:2000, CE certified.

FDA Registration Number: 8040374
US Agent: David Lennarz / Registrar Corp
Phone: +1-(757)-224-0177  Fax: +1-(757)-224-0179  E-Mail:

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• 5'-Nucleotidase 5-AMP-Phosphate Release (Colorimetric Test) (FDA Code: CED / 862.1520) A 5'-nucleotidase test system is a device intended to measure the activity of the enzyme 5'-nucleotidase in serum and plasma. Measurements of 5'-nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver and bone diseases in the presence of elevated serum alkaline phosphatase activity.

• ABO Blood Grouping Antiserum

• Acid Phosphatase, Naphthyl Phosphate Test (FDA Code: CKB / 862.1020) An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

• Acid Phosphatase, Nitrophenylphosphate Test (FDA Code: CJN / 862.1020)

• Acid, Hydroxyazobenzene-Benzoic, Albumin (FDA Code: CJZ / 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.

• Acquired Immune Deficiency Syndrome (AIDS) Antibody Test

• Alkaline Phosphatase (ALP) (FDA Code: JCJ / 864.7660) A leukocyte alkaline phosphatase test is a device used to identify the enzyme leukocyte alkaline phosphatase in neutrophilic granulocytes (granular leukocytes stainable by neutral dyes). The cytochemical identification of alkaline phosphatase depends on the formation of blue granules in cells containing alkaline phosphatase. The results of this test are used to differentiate chronic granulocytic leukemia (a malignant disease characterized by excessive overgrowth of granulocytes in the bone marrow) and reactions that resemble true leukemia, such as those occuring in severe infections and polycythemia (increased total red cell mass).

• Alkaline Phosphatase, Phenylphosphate Test (FDA Code: CKF / 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.

• 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.

• ALT/SGPT Vanillin Pyruvate Test (FDA Code: CKC / 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.

• 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).

• Amyloclastic, Amylase (FDA Code: CJA / 862.1070)

• Anti-acetylcholine Receptor Alpha Monoclonal Antibody

• Antistreptolysin-Titer/Streptolysin O Reagent (FDA Code: GTQ / 866.3720)

• AST/SGOT Catalytic Method Test

• 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.

• AST/SGOT Vanillin Pyruvate Test (FDA Code: CIF / 862.1100)

• 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 Urea Nitrogen (BUN) Reagent

• Bromcresol Green Dye-Binding, Albumin (FDA Code: CIX / 862.1035)

• Brucella Spp Agglutination Antigen (FDA Code: GSO / 866.3085)

• BUN (Blood Urea Nitrogen) Analyzer

• C-Reactive Protein Test System (FDA Code: DCN / 866.5270) A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

• 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)

• Chloride Test System (FDA Code: CHJ / 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.

• Cholesterol Colorimetric Test (FDA Code: CGO / 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.

• Cholinesterase Colorimetry Test (FDA Code: DIH / 862.3240) A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

• Colorimetric SGPT Test (FDA Code: CKD / 862.1030)

• 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.

• Control Antiserum Antigen Cholinesterase

• Creatine Phosphate Kinase Reagent Test

• Creatinine Enzymatic Method Test (FDA Code: JFY / 862.1225)

• Cytochemical, Acid Phosphatase (FDA Code: JCI / 864.1850) Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

• Detergent (FDA Code: JCB / 864.4010)

• Determination Of Alkaline Phosphatase

• Differential Rate Kinetic Method, Isoenzymes (FDA Code: JHS / 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.

• Electrolyte Control (FDA Code: JJR / 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.

• Enzymatic Esterase-Oxidase, Cholesterol (FDA Code: CHH / 862.1175)

• Enzyme Controls (FDA Code: JJT / 862.1660)

• Enzyme Immunoassay Test

• Febrile Antigen (FDA Code: GSZ / 866.3410)

• Febrile Antigens Slide/Tube Test (FDA Code: GNC / 866.3550)

• 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.

• Fertility Products, Isotonic Solution

• Fluorometric Calcium (FDA Code: JFO / 862.1145)

• Gamma-Glutamyl Transpeptidase Colorimetric Method (FDA Code: JPZ / 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.

• Gamma-Glutamyl Transpeptidase Kinetic Method (FDA Code: JQB / 862.1360)

• Glucose Oxidase, Glucose (FDA Code: CGA / 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.

• HDL Precipitation Method (FDA Code: LBR / 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.