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The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K2-EDTA, sodium citrate, lithium heparin, or sodium heparin). The testing system is designed for point-of-care settings, hospitals, and medical lab facilities. Estimation of hematocrit, as a function, is only for normal hemoglobin values, 12.0 to 180 g/dL) and in patients ≥ 6 months old. The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration. The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. The hemochroma PLUS System is for in vitro diagnostic only. The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglobin concentration in terms of g/dL.

The hemochroma PLUS Analyzer is a battery powered, hand-held device to measure the concentration of total hemoglobin in blood in 3 seconds with 15uL of whole blood. Whole blood may be collected by fingerstick (capillary) or venipuncture and analyzed without preprocessing. The hemochroma PLUS Analyzer uses hemochroma PLUS Microcuvettes with dual ports where the user applies samples either through capillary action or direct volume pipetting. The hemochroma PLUS Analyzer determines hemoglobin concentration in whole blood samples using a dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer. The optical distance between the hemochroma PLUS 3 Microcuvette walls is fixed and permits photometric determination of hemoglobin in undiluted blood samples. The computed end result is displayed on the LCD display and can be printed on an external printer (optional). The hemochroma PLUS System consists of a hemochroma PLUS Analyzer, single-use hemochroma PLUS Microcuvettes, hemochroma PLUS ID Chip, optical System Check Microcuvette and hemochroma PLUS Controls.

The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K.2-EDTA, sodium citrate, lithium heparin, or sodium heparin) of adults. The testing system is designed for point-of-care use in primary care settings, hospitals, and medical lab facilities. Estimation of hematocrit, as a function, is only for normal hemoglobin values from 12.0 to 18.0 g/ dL (120 to 180 g/L). The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration. The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. This device has not been evaluated for pediatric samples. The device has been evaluated for individuals ranging in age from 18 to 96 years old. The hemochroma PLUS System is for in vitro diagnostic only.

The hemochroma PLUS Analyzer is a battery powered, hand-held device to measure the concentration of total hemoglobin in blood in 3 seconds with 15ul of whole blood. Whole blood may be collected by fingerstick (capillary) or venipuncture and analyzed without pre-processing. The hemochroma PLUS Analyzer uses hemochroma PLUS Microcuvettes with dual ports where the user applies samples either through capillary action or direct volume pipetting. The hemochroma PLUS Analyzer determines hemoglobin concentration in whole blood samples using a dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and permits photometric determination of hemoglobin in undiluted blood samples. The computed end result is displayed on a LCD display and can be printed on an external printer (optional). The hemochroma PLUS System consists of a hemochroma PLUS Analyzer, single-use hemochroma PLUS Microcuvettes, hemochroma PLUS ID Chip, optical System Check Microcuvette and hemochroma PLUS Controls. 1. hemochroma PLUS Microcuvette The hemochroma PLUS Microcuvettes are specially designed for use with the hemochroma PLUS Analyzer. The microcuvettes function as measuring devices specifically holding 15 uL of blood and are inserted into the hemochroma PLUS Analyzer by placing it into the cuvette holder. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and by measuring the degree of light absorption permits photometric determination of the hemoglobin in undiluted blood samples. 2. hemochroma PLUS ID Chip The hemochroma PLUS ID chip contains encoded memory with the calibration data/information. With the ID chip inserted in the designated port, the hemochroma PLUS Analyzer reads and utilizes the calibration data regarding the lot under consideration and applies appropriate correction to the conversion formula while computing the test result. 3. hemochroma PLUS Optical System Check Microcuvette hemochroma PLUS Optical System Check Microcuvette is designed for use with the hemochroma PLUS Analyzer only. The Optical System Check Microcuvette is a special glass filter used to measure the degree of light absorption with the spectrophotometric method. If the result is between 11.7-12.3 g/dL, the optic system is working properly according to specification. 4. hemochroma PLUS Controls The hemochroma PLUS Controls: Level 1 (Low), Level 2 (Middle), and Level 3 (High), are external quality controls designed for use with hemochroma PLUS Analyzer only.

AFIAS iFOB in conjunction with AFIAS 50 is a fluorescence immunoassay system for qualitative detection of fecal occult blood (FOB) in human fecal samples. AFIAS iFOB is an in vitro diagnostic test used by professional clinical laboratories and clinical reference laboratories for routine physical examination when gastrointestinal bleeding may be suspected. Intended users/operators for AFIAS iFOB is professional medical personnel.

AFIAS iFOB in conjunction with AFIAS-50 is a fluorescence immunoassay system for qualitative detection of fecal occult blood (FOB) in human fecal samples. Components of AFIAS iFOB: AFIAS iFOB consist of a test cartridge, ID chip, sample collection tube contain the extraction buffer, package insert, applicator sticks, collection slide, mailing envelope, sample collection tissues, instruction for use and patient instructions. The AFIAS iFOB test cartridge contains a test strip; with a nitrocellulose membrane of which, mouse monoclonal anti hemoglobin labeled with fluorescence and anti rabbit IgG labeled fluorescence have been immobilized at the glaze line, mouse monoclonal anti hemoglobin at the test line and rabbit IgG at the control line. Each test cartridge is individually sealed in an aluminum foil pouch containing a desiccant. Twenty-five sealed test cartridges are packed in a box which also contains an ID chip and 25 mailing envelopes which contain a collection slide, applicator sticks and sample collection tissues. The ID chip contains a memory device that contains encoded calibration data/information for the batch (lot-to-lot) variation. With the ID chip inserted in the designated port, AFIAS-50 reads and utilizes the calibration data regarding the batch/lot under consideration and applies appropriate correction to the conversion formula while computing the test result. The AFIAS iFOB extraction buffer tube with extraction buffer is sealed with plastic caps. The upper side is capped with a plastic cap without a sampling stick. The bottom side is capped with a plastic cap with a sampling stick. The extraction buffer contains bovine serum albumin (BSA) as a stabilizer, tween 20 as a surfactant and sodium azide in phosphate buffered saline (PBS) as a preservative. Each extraction buffer tube contains 1 mL extraction buffer. Twenty-five pre-filled extraction buffer tubes are packed in a test cartridge box. Components of AFIAS-50: Power cable, Barcode reader, Thermal printer paper, Collection tube rack holder, Sample tips, Test cartridge magazine, Waste bin, System check cartridge set.

The Hema-Screen TM Specific Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

hema-screen™ SPECIFIC Gold is a qualitative, sandwich dye conjugate immunoassay that employs a unique combination of monoclonal antibodies to selectively identify the globin component of human hemoglobin in fecal specimens with a high degree of analytical sensitivity. Two samples of feces, collected using the unique DEVEL-A-TAB Sampler, are dispersed in a single tube containing a known volume of buffer. The unique design of the Sampler ensures that a controlled amount of feces is added to the specimen preparation tube. Then, the feces in buffer is transferred to the test cassette detection system using the tube itself as the delivery system. In less than five minutes, unusually elevated concentrations of human hemoglobin in feces can be detected and positive results for abnormal concentrations of hemoglobin can be seen in the test cassette detection system as early as two or three minutes after application of specimen. As the feces in buffer specimen flows up through the absorbent device, the labeled antibody-dye conjugate binds to the globin of hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to anti-globin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly. In the extremely rare event of operator or test cassette failure, sufficient specimen is available in the tube to repeat the procedure with another test cassette.

hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

hema-screen ER XCEL™ in its original concept as slides and tape was designed to offer the hospital, mass screening programs and clinical laboratories a convenient rapid method for handling fecal specimens in testing for occult blood. hema-screen ER XCEL™ is especially useful for mass screening programs as its enhanced readability feature facilitates the technicians' ability to make a determination. hema-screen ER XCEL™ eliminates the mess and odors associated with the collection and transport of fecal specimens. Slides can be prepared at the patient's bedside and placed in a sealed envelope or by the patient at home and mailed to the hospital or laboratory in an inoffensive manner for development and evaluation. hema-screen ER XCEL™ single slides are convenient for use when single stool specimens are to be tested. A single test is indicated when blood loss in the gastrointestinal tract is strongly suspected, for example, in persons with symptoms of ulcers, anemia, black stools or postoperative patients. hema-screen ER XCEL™ Enhanced Readability Patient Packs are to be utilized so the patient can serially collect specimens at home over the course of three bowel movements. Patients should be instructed to follow the directions exactly, as the potential for false positive results exists due to improper diet, blood on the hands, hemorrhoids or if the test is used during menstrual bleeding. After all three slides are prepared, the slides may be sent back to the hospital laboratory for developing and evaluation. Preparation of three consecutive slides is recommended for screening asymptomatic patients by the American Cancer Society. When stool specimens containing occult blood are applied hema-screen ER XCEL™ test paper, the hemoglobin portion of the occult blood comes in contact with the guaiac. When the hema-screen ER XCEL™ peroxide developing solution is added, a guaiac-peroxidase like reaction occurs. The chemical reaction becomes visible by the appearance of a blue-green color between 30 seconds and 60 seconds if occur blood is present.

hema-screen™ ER is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

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The Hema-Screen™ Specific is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

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The Immuno / hCG Detector™ - Urine is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only. The Immuno / hCG Detector Stix is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only. The Immuno / hCG Detector Combi™ is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

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The RUBELLACOL™ TEST is to be used as an aid in the detection of anti-rubella virus antibodies in serum. This test is "For Professional Use Only".

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COLON ALERT is a rapid, convenient and non-offensive aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the asyniptomatic "gastronitestinal" ocharities" than may of the COUNTER USE". presence of occult blood in the stool. "This test is "FOR OVER-THE COUNTER USE".

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