Profile: Abbott Diagnostics specializes in pharmaceutical, nutritional, diagnostic instruments, surgical devices, and medical devices. Our medical diagnostic instruments and tests are used in hospitals, reference labs, blood banks, physician offices, clinics and at home to diagnose a range of serious health issues such as infectious diseases, cancer, diabetes and genetic conditions, as well as monitor other important indicators of health. The cornerstone of our diagnostic products is immunodiagnostics, the science of measuring the body's antigen/antibody reactions to detect diseases and other medical conditions. Our molecular diagnostics help physicians detect genetic mutations in patients genes and chromosomes to detect and manage disease. Hand-held point of care diagnostics and blood glucose monitoring devices provide health care professionals and patients with fast, convenient and accurate test results Our Abbott Prism® is a throughput, automated test system for blood screening. We render numerous diagnostic tests for the monitoring & diagnosis of conditions related to the endocrine glands. Our IMx system is an automated analyzer designed to perform microparticle enzyme immunoassay (MEIA), fluorescence polarization immunoassay (FPIA) and ion capture technologies.

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• Differential Cell Counter (FDA Code: GKZ / 864.5220) An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

• Diphenylhydantoin Enzyme Immunoassay Test (FDA Code: DIP / 862.3350) A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

• 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.

• Drugs Of Abuse Test Kits

• 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.

• 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.

• Fluorescence In Situ Hybridization Systems

• Fluorometer for Clinical Use (FDA Code: KHO / 862.2560) A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.

• 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.

• General Chemistry Calibrators

• General Chemistry Kits

• General Chemistry Test Kits

• Genetic Analysis Systems

• Genetic Analyzer

• Genomic Hybridization Systems

• Glucose

• Glucose Analyzers

• 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 Kits

• Glucose Test Kits

• Hamatology Instruments, Hematology Workcells

• Haptoglobin (FDA Code: DAD / 866.5460) A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

• Hematology Analyzers

• Hematology Controls Cbc

• Hematology Reticulocyte Controls

• Hematology Slide Stainer Instruments

• Hematology Workcells

• Hematology Workcells Automation System

• Hepatitis B Surface Antigen Test Kits

• HIV Screening - ELISA

• Hormone Reagents & Test Kits

• Hormone Test Kits

• Human Myoglobin ELISA Kits

• IGA Control (FDA Code: CZP / 866.5510) An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

• IgG Control (FDA Code: DEW / 866.5510)

• Immunoassay Equipment, Immunochemistry Analyzers

• Immunoassay Kits Tumor Markers

• Immunoassay Reagents & Test Kits

• Immunoassay Systems

• Immunoassays

• Immunochemistry Analyzers

• Immunoglobulin M (IgM) (FDA Code: DFT / 866.5550) An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

• In Situ Hybridization Systems

• Incubator/ Water Bath (FDA Code: JTQ / 866.2540) A microbiological incubator is a device with various chambers or water-filled compartments in which controlled environmental conditions, particularly temperature, are maintained. It is intended for medical purposes to cultivate microorganisms and aid in the diagnosis of disease.

• Infectious Disease Identification Test Kits

• 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.

• Instruments, Immunoassays

• Iron Reagent (FDA Code: CFM / 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.

• Ketone Analyzers