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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• Maternal/Fetal Monitor System

• Measles Virus PHA Torch Test Kit

• Media Dispensing/Stacking Device (FDA Code: JTB / 866.2440) An automated medium dispensing and stacking device is a device intended for medical purposes to dispense a microbiological culture medium into petri dishes and then mechanically stack the petri dishes.

• Medical Otoscopes

• Medical Record Chart Paper

• Methamphetamine High Pressure Liquid Chromatography Test (FDA Code: LAG / 862.3610) A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

• Micro and Benchtop Centrifuges Refrigerated Centrifuges

• Micro Centrifuge Tube Storage Box

• Micro Chemistry Analyzer (FDA Code: JJF / 862.2170) A micro 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. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

• 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.

• Micro Pipette Tips and Tip Racks

• Micro Sedimentation Centrifuge (FDA Code: GHK / 864.5350) A microsedimentation centrifuge is a device used to sediment red cells for the microsedimentation rate test.

• Micro Surgery Instruments

• Micro Surgery Instruments, Graspers

• Micro Surgery Instruments, Pneumatic Power Systems

• Micro Surgery Instruments, Scissors

• Micro Ultracentrifuges

• Microalbumin Urine Test Kits

• Microcentrifuge Tubes

• Microcentrifuges

• Microcentrifuges Non-Refrigerated

• Microelectrode

• Microhematocrit Centrifuges

• Microhematocrit Centrifuges

• Microplate Washers

• Microscope Filter Sets

• Microscope Objective Lenses

• Microscope Plastic Dust Covers

• Microscope Protective Covers

• Microscope Slide Staining Kit

• Microscopes

• Microscopes & Telescopes

• Microscopes, Digital Image Capture Systems

• Microscopes, Image Capture System

• Microscopes, Inverted Microscope Objectives

• Microscopy Accessories, Microscope Dust Covers

• MiniFuge Microcentrifuges

• Molecular Diagnostics, Automated Sequencers

• Monoclonal Antibody Test

• Motorized Inverted Microscope

• Mouse Anti-Human Prostatic Acid Phosphatase (PSAP) Detection Kit

• Mu-chain Specific Antisera (FDA Code: DAO / 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.

• 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.)

• Multi-Label Microplate Readers

• Multichannel Hematology Analyzers

• Multiple Immunoassay Systems

• Multiplexed SNP Genotyping System

• Mumps Virus Enzyme Linked Immunoabsorbent Assay (FDA Code: LJY / 866.3380) Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.

• 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.