Abbott Hematology


Contact: Miles D. White - CEO & Chairman
Web: http://www.abbott.us
Address: 5440 Patrick Henry Dr., Santa Clara, California 95054, USA
Phone: +1-(408)-982-4800 | Fax: +1-(408)-982-4864 | Map/Directions >>
 
 

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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• Acetaminophen Colorimetry Test (FDA Code: LDP / 862.3030)
An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
• 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.
• Activated Whole Blood Clotting Time (FDA Code: JBP / 864.7140)
An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.
• Alcohol Dehydrogenase, Specific Reagent for Ethanol Enzyme Method (FDA Code: DIC / 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.
• 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.
• Alpha-1-Lipoprotein (FDA Code: DER / 866.5580)
Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).
• Alpha-Fetoprotein for Testicular Cancer Test Kit (FDA Code: LOJ / 866.6010)
A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
• Alpha-Fetoprotein Test for Neural Tube Defect Test (FDA Code: LOK)
• Amikacin Radioimmunoassay Test (FDA Code: KLQ / 862.3035)
An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.
• Amphetamine Enzyme Immunoassay Test (FDA Code: DKZ / 862.3100)
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020)
Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:
• Anesthetic Infusion Pump (FDA Code: FRN / 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.
• Angiographic Injector and Syringe (FDA Code: DXT / 870.1650)
An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.
• Arterial Blood Sampling Kit (FDA Code: CBT / 868.1100)
An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.
• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 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.
• 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 Bloodborne Pathogen Test Equipment (FDA Code: MZA)
• Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays System (FDA Code: NTH / 866.4700)
• Automated Slide Spinner (FDA Code: GKJ / 864.5850)
An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm).
• Automated Tissue Stainer (FDA Code: KEY / 864.3800)
An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
• Balloon Inflation Syringe (FDA Code: MAV / 870.1650)
• Barbiturate Enzyme Immunoassay Test (FDA Code: DIS / 862.3150)
A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.
• Benzodiazepine Enzyme Immunoassay Test (FDA Code: JXM / 862.3170)
A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.
• 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.
• Bladder Tumor Marker Monitoring Test (FDA Code: MMW / 866.6010)
• Blood Bank Software (FDA Code: MMH / 864.9175)
An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.
• Blood Cell Diluent (FDA Code: GIF / 864.8200)
A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
• Blood Collection Lancet (FDA Code: FMK / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• 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.
• 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 Ion Specific Electrode (FDA Code: JFP / 862.1145)
• Cannabinoids Enzyme Immunoassay Test (FDA Code: LDJ / 862.3870)
A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.
• Capillary Blood Collection Tubes (FDA Code: GIO / 864.6150)
A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.
• Carbamazepine Enzyme Immunoassay Test (FDA Code: KLT / 862.3645)
A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.
• Carbamazepine Fluorescence Polarization Immunoassay Test (FDA Code: LGI / 862.3645)
• Carbon-Dioxide Enzymatic (FDA Code: KHS / 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.
• Carbon-Dioxide pH Rate Measurement Test (FDA Code: JFL / 862.1160)
• Carcinoembryonic Antigen Test System (FDA Code: DHX / 866.6010)
• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290)
A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
• Carotid Stent (FDA Code: NIM)
• Carotid Stent Systems (FDA Code: NIM)
• Catheter Adaptor (FDA Code: GCE / 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.
• Catheter Introducers (FDA Code: DYB / 870.1340)
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
• 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.
• Clinical Colorimeter (FDA Code: JJQ / 862.2300)
A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.
• Clinical Sample Concentrator (FDA Code: JJH / 862.2310)
A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.
• Cocaine and Cocaine Metabolites Enzyme Immunoassay Test (FDA Code: DIO / 862.3250)
A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
• Complement C3 (FDA Code: CZW / 866.5240)
A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

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