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"OC-Auto Sensor io iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitatitye detection of fecal occult blood in feces by professional laboratories. The automated test is used for the measurement of fecal occult blood and is useful as an aid to detect blood in stool when lower gastrointestinal bleeding may be suspected.

OC-Auto Sensor io iFOB Test is intended for the automated in vitro qualitative detection of fecal occult blood in feces by professional laboratories. The test system is comprised of test reagents (latex, diluent buffer, wash concentrate, calibrator, negative and positive controls), sample collection bottles and analyzer. The principle of measurement employed for the reagent system is latex agglutination. A latex agglutination reaction is the clumping of antibody-sensitized polystyrene latex particles through an antigen-antibody reaction. A light beam is passed through the reaction liquid to measure changes in the intensity of the transmitted light beam (latex turbidimetry), and changes in the intensity of the scattered light beam (latex nephelometry). With OC-Auto Sensor io iFOB Test analyzer, latex turbidimetry is used to measure the amount of an antigen or an antibody by measuring changes in scattered light rays in latex agglutination. The throughput of the instrument is 88 samples per hour. The samples are collected in the sample collection bottles that are sent home with the patient. The sample collection bottles are then returned to the laboratory. The inverted sample collection bottles are racked and placed onto the instrument platform. The sample collection bottle is punctured and a sample is pipet into the cuvette followed by the latex reagent and mixed. Measurements are taken between the mixing cycles. After a series of washes the blank is read and the final results calculated and printed.

"OC-Sensor DIANA iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders (GI), e.g. colitis, polyps, and colorectal cancer. The OC-Sensor DIANA iFOB test is recommended for use in: 1. Routine physical examinations 2. Monitoring bleeding in patients 3. Screening for colorectal cancer or gastrointestinal bleeding

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