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The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The POC-AS10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer. The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.

The POC-AS10 Auto sampler is an optional accessory to the POCone Infrared Spectrophotometer. The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The POC-AS10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer. By connecting the POC-AS10 Auto sampler to the POCone Infrared Spectrophotometer, up to ten pairs of breath collection bags (20 bags total) can be set up at one time.

The RAPIRUN H. pylori Antibody Detection Kit is a rapid immunochromatographic assay intended for the qualitative detection of antibodies against Helicobacter pylori (H. pylori) in urine to aid in the diagnosis of H. pylori infection. The RAPIRUN Kit is suitable for use in both point-of-care and clinical laboratory settings.

The RAPIRUN H. pylori Antibody Detection Kit is an immunochromatographic method for the qualitative detection of anti-H. pylori antibodies in urine using a nitrocellulose membrane immobilized with proteins extracted from H. pylori as an antigen. The test device includes a sample window in which the test specimen is placed in a dropwise manner and an evaluation window in which a test line and a control line are visible. Colloidal gold-conjugated anti-human IgG (Fc) polyclonal antibody (goat) is present between the sample window and the evaluation window. The test line and the control line in the evaluation window are immobilized with H. pylori-extracted protein and with anti-human IgG polyclonal antibodies (goat), respectively. When a urine specimen diluted with the sample diluent is added dropwise to the sample window, the IgG in the diluted sample reacts with the conjugated antibodies. Immunocomplexes are formed and flow into the nitrocellulose membrane. If anti-H. pylori IgG antibody complexes are present in these immunocomplexes, they react with the H. pylori antigen immobilizing on the test line and are captured producing a red band. On the other hand, immunocomplexes without anti-H. pylori IgG antibodies pass the test line and are captured by the anti-human IgG polyclonal antibodies (goat) immobilizing on the control line producing a red band. A test specimen is judged to be positive for anti-H. pylori antibodies if red colored bands appear in both the test zone and the control zone, or is judged to be negative for anti-H. pylori antibodies if a red colored band only appears in the control zone.

The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis. The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.

The POCone Infrared Spectrophotometer is a compact analyzer designed for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori. The POCone measures absorption of breath gas by calculating the ratios of 13CO2/12CO2 for a reference breath gas and a sample breath gas. The difference between the ratios for the reference and sample breath gases is calculated to obtain the final measurement result, which is reported as A13CO2, and expressed as delta per mil (%) or Delta Over Baseline (DOB).

The UBiT-IR300 Infrared Spectrometry System is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The system consists of the UBiT-IR300 Infrared Spectrophotometer, the UBiT-AS10 Autosampler, and Otsuka Breath Collection Bags. The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The UBiT-IR300 System is suitable for use in both clinical laboratory and point-of-care settings.

The UBiT-IR300 Infrared Spectrometry System is a compact analyzer designed for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori. The UBiT-IR300 measures absorption of breath gas by calculating the ratios of 13CO2/12CO2 for a reference breath gas and a sample breath gas. The difference between the ratios for the reference and sample breath gases is calculated to obtain the final measurement result, which is reported as △'3CO2 and expressed as delta per mil (%) or Delta Over Baseline (DOB). The System consists of the following components: - UBiT-IR300 Infrared Spectrophotometer - - UBiT-AS10 Autosampler - - Otsuka Breath Collection Bags -

The RLP-Cholesterol Assay is intended for use in the quantitative determination of cholesterol contained in remnant lipoproteins in human serum or plasma. The test results are used in combination with total serum triglyceride measurements to aids in the diagnosis of familial type III hyperlipoproteinemia in patients with serum total cholesterol concentration ≥ 200 mg/dL and triglyceride concentrations between 200 and 800 mg/dL.

The RLP-Cholesterol Assay uses two mouse monoclonal antibodies (Mab) to isolate remnant lipoproteins. The first one (JI-H) is raised against human apo B-100. This Mab recognizes an epitope near the apo B-51 region to remove lipoproteins containing apo B-100, such as LDL, Lp(a) and nascent VLDL. The second one (H-12) is raised against human apo A-I. This Mab removes lipoproteins containing apo A-I, such as HDL. The monoclonal antibodies are conjugated to sepharose-4B beads and to separate bound lipoproteins from the remnant lipoproteins that remain in the unbound fraction. Cholesterol in the unbound fraction (RLP-C) is then quantified by an enzymatic assay.