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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• Blood Lancets

• Blood Perfusion Monitor

• Blood Platelet Incubator

• Blood Ports

• Blood pressure Cuffs (FDA Code: DXQ / 870.1120) A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

• Blood Pressure kits

• Blood Pressure Measuring Equipment

• Blood Pressure Monitors

• Blood Pressure Monitors

• Blood Tube Mixer (FDA Code: GLE / 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.

• Blood Tubing Sets

• Blood Urea Nitrogen (BUN) Reagent

• Blood, Hematology Analyzers

• Blood, Hemoglobin Analyzers

• Bloodborne Pathogen Clean-Up Kit

• 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.

• BUN (Blood Urea Nitrogen) Analyzer

• C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD / 862.1135) A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.

• 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 Atomic Absorption Test (FDA Code: JFN / 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 Azo-Dye (FDA Code: CJY / 862.1145)

• Calcium Cresolphthalein Complexone Test (FDA Code: CIC / 862.1145)

• Calcium Ion Specific Electrode (FDA Code: JFP / 862.1145)

• Calibration Reagent

• Calibrators & Controls, Blood Gas, Electrolytes

• Calibrators for Equipment

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• Cancer Test Kits

• Cancer Tumor Markers

• 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.

• Carbohydrate Antigen (Ca19-9) Test System For Monitoring And Management Of Pancreatic Cancer (FDA Code: NIG / 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.

• Carbon-Dioxide Coulometric Method Test (FDA Code: CHS / 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 Enzymatic (FDA Code: KHS / 862.1160)

• Carbon-Dioxide pH Rate Measurement Test (FDA Code: JFL / 862.1160)

• Carcinoembryonic Antigen Test System (FDA Code: DHX / 866.6010)

• Cardiac C-Reactive Protein Antiserum Antigen Control (FDA Code: NQD / 866.5270)

• Cardiac Markers kits

• Casting Materials

• Casting Materials and Equipment, Casting Stands

• Cell Counter

• Cell Counter Instruments

• Cell Fractionator

• Cell Indices Calibrator (FDA Code: KRX / 864.8150) A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.

• Cell Sorter (FDA Code: KEX)

• Centrifugal Chemistry Analyzer (FDA Code: JJG / 862.2140) A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

• Centrifuges

• Centrifuges, Personal Microcentrifuges

• Chemistry Analyzers