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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• Platelet Counting Calibrator (FDA Code: KRY / 864.8175) A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used to set a platelet counting instrument. It is a suspension of particles or cells whose size, shape concentration, and other characteristics have been precisely and accurately determined.

• Plus Blood and Fluid Warmers

• Pocket Halogen Otoscopes

• Point-of-care (POC) Coagulation Analyzers

• Polyclonal Antibody

• Polyclonal Antibody Goat Anti-HbsAg IgG

• Polyclonal Antibody Goat Anti-human IgG

• Polyclonal Antibody Goat Anti-mouse IgG

• Polyclonal Antibody Goat Anti-rabbit IgG

• Polyclonal Antibody Goat Anti-whole hCG

• Polynucleotide Synthesizer

• Portable Handheld pH Meters

• Portable Inverted Microscope

• Potassium Ion Specific Electrode (FDA Code: CEM / 862.1600) A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

• Prealbumin (FDA Code: DDS / 866.5060) A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.

• Prealbumin Antiserum (FDA Code: JZJ / 866.5060)

• Pregnancy Kits

• Pregnancy Testing Kits

• Preparative Ultracentrifuges

• Primary Calibrator (FDA Code: JIS / 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.)

• Product Development, Micro pH Electrodes

• Progesterone

• Progesterone - 17-OH Testing Kit

• Progesterone Hormone

• Progesterone Injections

• Progesterone Pills

• Progesterone Radioimmunoassay Test (FDA Code: JLS / 862.1620) A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

• Progesterone Supplements

• Programmable Multi-Channel Chemistry Analyzer

• Programmable Single Channel Chemistry Analyzer

• Prolactin (rat) EIA Kit

• Prolactin ELISA Kit

• Prolactin Kit

• Prolactin Radioimmunoassay (FDA Code: CFT / 862.1625) A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

• Propoxyphene High Pressure Liquid Chromatography Test (FDA Code: LAK / 862.3700) A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

• Prostate Specific Antigen Test (FDA Code: MTG)

• Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer Total (FDA Code: MTF)

• Prostatic Acid Phosphatase

• Protein /Albumin Turbidimetric Method (FDA Code: JIQ / 862.1645) A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

• Protein Analyzer

• Protein Fractionation Electrophoretic Test (FDA Code: CEF / 862.1630) A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.

• Proteinomics

• Pyrex Test Tubes

• Quality Assessment Programs

• Quality Assurance

• Quality Control Kit for Blood Banking Reagents (FDA Code: KSF / 864.9650) A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.

• Quality Control Reagent

• Quinine High Pressure Liquid Chromatography Test (FDA Code: LAM / 862.3750) A quinine test system is a device intended to measure quinine, a fever-reducing and pain-relieving drug intended in the treatment of malaria, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of quinine overdose and malaria.

• Racked Non-Sterile Non-Barrier Multi-Channel Pipette Tips

• Racked Non-Sterile Non-Barrier Pipette Tips