Profile: Abbott Hematology offers pharmaceutical, medical, and nutritional products. Our product range comprises of medicines, medical diagnostic instruments & tests, minimally invasive surgical devices, and a spectrum of nutritional supplements for infants, children & adults. Our perclose A-T suture medicated closure provides the security of a braided polyester suture and ease of an automated knot for vascular closure. It is designed to provide complete tissue apposition resulting in primary healing. It provides reduced time to hemostasis ambulation and discharge. Our perclose proglide suture mediated closure is a monofilament suture that ensures vessel closure.

The company has ~72000 employees and is ISO 9001, CE certified. NYSE:ABT (SEC Filings)

FDA Registration Number: 2919069

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• Hemoglobin and Hematocrit Measurement Calibrator (FDA Code: KRZ / 864.8165) A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.

• Hepatitis A Test (FDA Code: LOL / 866.3310) HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.

• Hepatitis B Antigen Identification System (FDA Code: KSJ)

• Hepatitis B Test (FDA Code: LOM)

• Hepatitis B Viral DNA Detection (FDA Code: MKT)

• Hepatitis C Virus Enzyme Linked Immunosorbent Assay (FDA Code: MZO)

• Hepatitis C Virus Genotyping Assay (FDA Code: OBF)

• HIV Detection Test (FDA Code: MZF)

• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155) A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.

• Human Chromosome DNA-Probe (FDA Code: MAO)

• Hybridization And/Or Nucleic Acid Amplification Assay For Detection Of Hepatitis C Rna, Hepatitis C Virus (FDA Code: MZP)

• Hydroxybutyric Dehydroge Dinitrophenyl Hydrazone Measurement (Colorimetric) (FDA Code: JKF / 862.1380) A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.

• 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)

• 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.

• 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.

• Infusion Stand (FDA Code: FOX / 880.6990) The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.

• 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.

• Insulin Infusion Pump (FDA Code: LZG / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Invasive Glucose Sensor (FDA Code: MDS)

• Ion Electrode Based Enzymatic Creatinine (FDA Code: CGL / 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.

• 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.

• Irrigation Catheter (FDA Code: GBX / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Isoenzymes Colorimetric Method (FDA Code: JHY / 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.

• Isoenzymes NAD Reduction/NADH Oxidation (FDA Code: CGS / 862.1215)

• Knot Pusher

• 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.

• Lactic Acid Enzymatic Method (FDA Code: KHP / 862.1450) A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

• 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.

• Lecithin/Sphingomyelin Ratio Colorimetric Method (FDA Code: JHF / 862.1455) A lecithin/sphingomyelin ratio in amniotic fluid test system is a device intended to measure the lecithin/sphingomyelin ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats or fat-like substances containing phosphorus). Measurements of the lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating fetal maturity.

• Lipase Photometric Enzymatic Lipase-Esterase Test (FDA Code: CHI / 862.1465) A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

• Low Density Lipoprotein (FDA Code: DFC / 866.5600) A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

• Luteinizing Hormone Radioimmunoassay (FDA Code: CEP / 862.1485) A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

• 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).

• Medical Devices

• Methadone Enzyme Immunoassay Test (FDA Code: DJR / 862.3620) A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

• Methotrexate Enzyme Immunoassay (FDA Code: LAO)

• Micro Pipette (FDA Code: JRC / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• 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.)

• Multiple Lumen Catheter (FDA Code: GBP / 878.4200)

• Myoglobin (FDA Code: DDR / 866.5680) A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

• N-Acetylprocainamide Enzyme Immunoassay Test (FDA Code: LAN / 862.3320) A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

• NAD/NADH Reagent for Alcohol Enzume Method (FDA Code: DML / 862.3040) An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

• 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.

• Natriuretic Peptide Test (FDA Code: NBC / 862.1117) The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

• Neisseria DNA Reagents (FDA Code: LSL / 866.3390)

• Neonatal Total Bilirubin Test System (FDA Code: MQM / 862.1113) A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

• Normal and Abnormal Cell Counter Control (FDA Code: JCN / 864.8625) A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

• Nucleic Acid Amplification Test for Chlamydia (FDA Code: MKZ / 866.3120) Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).