Profile: Beckman Coulter, Inc. is a manufacturer of biomedical testing instrument systems, tests & supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum from medical research & clinical trials to laboratory diagnostics and point-of-care testing, we provide essential biomedical information. GenomeLab is a family of solutions that identifies & removes the bottlenecks in the study of genetics, with the ultimate goal of identifying disease targets for therapy. We also render in vitro diagnostics systems to hospital laboratories. Our Hemoccult® ICT is the latest and most advanced fecal occult blood test (FOBT) in our Hemoccult product line. An immunochemical FOBT (iFOBT) with high specificity and sensitivity, Hemoccult ICT is clinically proven to detect bleeding associated with more cancers & polyps than traditional guaiac-based FOBTs. Because of its superior specificity for lower GI bleeding, Hemoccult ICT is an ideal screening tool for colorectal cancer (CRC), and this specificity also reduces the number of false positive test results.

The company was founded in 1934, has revenues of > USD 1 Billion, has ~10100 employees and is ISO 9000, ISO 9001, ISO 9002, CE certified.

FDA Registration Number: 2050012

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• General Chemistry Kits

• General Chemistry Test Kits

• General Diagnostic Supplies

• General Diagnostics

• General Examination Supplies

• General Laboratory Refrigerators and Freezer Combinations

• General Laboratory Timer (FDA Code: JBS / 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.

• General Medical Supplies

• General Purpose Reagent (FDA Code: LDT)

• General Surgery Supplies

• General Surgical Aids

• General Test Kits

• General Use pH Meter

• Genetic Analysis Systems

• Genetic Testing Equipment

• Gentamicin Enzyme Immunoassay Test (FDA Code: LCD / 862.3450) A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

• Gentamicin Hemagglutination Inhibition (FDA Code: DNO / 862.3450)

• Giant Test Tubes

• Glass Centrifuge Tube

• 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 Oxidase, Glucose (FDA Code: CGA / 862.1345)

• 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.

• Guaiac Reagent (FDA Code: GGG / 864.6550) An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

• Guinea Pig Anti-Insulin Detection Kit

• Hamatology Instruments, Hematology Workcells

• Handheld pH Meters

• 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.

• Helicobacter pylori Antibody Kits

• Hematocrit Centrifuge (FDA Code: GKG / 864.6400) A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.

• Hematology Analyzer Computer

• Hematology Analyzers

• Hematology Controls Cbc

• Hematology Instruments

• Hematology Quality Control Mixture (FDA Code: JPK / 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).

• Hematology Reagents

• Hematology Reagents and Kits

• Hematology Reagents and Kits Hemoglobin A1C (Glycohemoglobin)

• Hematology Reagents and Supplies

• Hematology Reticulocyte Controls

• Hematology Sedimentation Controls

• Hematology Slide Stainer Instruments

• Hematology Stain (FDA Code: KQC / 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.

• Hematology Workcells

• Hematology Workcells Automation System

• Hematology Wright's Stain

• Hemodialysis Blood Tubing Sets

• Hemoglobin A1c Analyzers

• Hemoglobinometer (FDA Code: GIG / 864.7500) A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

• High Performance Liquid Chromatography Analyzer