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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• Radioimmunoassay for Dehydroepiandrosterone Sulfate (FDA Code: JKC / 862.1245) A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

• Radioimmunoassay for Immunoglobulin G, A, M (FDA Code: CFQ / 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.

• Radioimmunoassay Kit For Prostatic Acid Phosphatase

• Radiology Computer Software

• Rapid Test Tumor markers

• RBC Folate Reagent Pack

• Reconditioned Cell Counters

• Red Blood Cell Storage Solutions

• Red Cell Lysing Fluid (FDA Code: GGK / 864.8540) A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

• Refrigerated Benchtop Centrifuges

• Refrigerated Centrifuges

• Refrigerated Centrifuges (FDA Code: JQC / 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.

• Refrigerated Floor Centrifuges

• Refrigerated Microcentrifuges

• Refrigerators

• Refurbished Hematology Analyzers

• Research Inverted System Microscope

• Retinal Blood Flowmeters

• Reusable Basic Labware

• Rheumatoid Factor Test System (FDA Code: DHR / 866.5775) A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

• Rhodamine Breast Milk Antiserum Antigen Control (FDA Code: DGI / 866.5170) A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins.

• Rhodamine Transferrin Antiserum Antigen Control (FDA Code: DDD / 866.5880) A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

• Rimmed Glass Test Tubes

• Rubella Enzyme Linked Immunoabsorbent Assay (FDA Code: LFX / 866.3510) Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

• Scales

• Scientific Microcentrifuges

• Scientific Microhematocrit Centrifuges

• Scientific Microscope Objectives

• Scintillation Counter

• Secondary Calibrator (FDA Code: JIT / 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.)

• semiautomated Specular Microscopes

• Sensitive Immunoassay Systems

• Sensitive Pregnancy Tests

• Sensitive Rat Insulin RIA Kit

• Serum Human Chorionic Gonadotropin Test (FDA Code: DHA / 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.

• Serum Prostatic Acid Phosphatase Test Kit

• Small Inverted Microscope

• Smaller Hematology Analyzers

• SNP (Short Nucleotide Polymorphism) Genotyping Systems

• Sodium Ion Specific Electrode (FDA Code: JGS / 862.1665) A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

• Sodium Potassium Analyzers

• Software Programs

• Specialty Diagnostic Supplies

• Specific Ion Electrode

• Spectrophotometer Cell

• Spectrophotometer Cuvette

• Spectrophotometer Solvent

• Spectrophotometers

• Standard Amino Acid

• Standard Cyanomethemoglobin Reagent (FDA Code: GJZ / 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.