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K-ASSAY® CRP (Ver.2) is intended to be used for the quantitative determination of C-reactive protein (CRP) in human serum and plasma (potassium-EDTA or lithium-heparin) by immunoturbidimetric assay. Measurement of CRP aids in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. FOR IN VITRO DIAGNOSTIC USE.

The K-ASSAY® CRP (Ver.2) assay quantifies C-reactive protein based on immunoturbidimetric assay. The reagent uses latex combined with goat polyclonal antibody specific to human CRP. By adsorbing CRP in the sample to the surface of the latex particles and reacting it with the anti-CRP antibody, specific aggregation corresponding to the CRP concentration occurs. Since the absorbance of the reaction changes in proportion to the amount of aggregation, the concentration of CRP in the sample is determined based on the calibration curve prepared using a standard of known CRP concentrations. The K-ASSAY® CRP (Ver.2) assay can be run using a chemistry analyzer. 6 levels of calibrators from the K-ASSAY® CRP Calibrator (Ver.2) calibrators are used for quantifying the levels of CRP present in the patient's sample.

The K-ASSAY® RF (Ver.2) assay is for the quantitative determination of human IgG rheumatoid factor antibodies in patient serum or plasma (citric acid, EDTA, or lithium heparin) based on immunoturbidimetric assay. The presence of IgG RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatord arthritis (RA). FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY® RF Calibrator (Ver.2) is intended to be used to calibrate the K-ASSAY® RF (Ver.2) immunoturbidimetric assay. FOR IN VITRO DIAGNOSTIC USE.

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The K-ASSAY® Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use. The K-ASSAY® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. For in vitro diagnostic use.

The K-ASSAY® Ferritin (2nd Gen.) assay is a latex enhanced immuno-turbidimetric assay for the quantitative in vitro determination of ferritin levels in serum and plasma (EDTA and heparin) samples. The K-ASSAY® Ferritin (2nd Gen.) consists of two reagents. Reagent 1 contains HEPES buffer solution (50 mmol/L) and Reagent 2 contains HEPES buffer solution (50 mmol/L) and a solution of latex suspension with mouse monoclonal anti-human ferritin antibodies. Both reagents also contain less than 0:01 w/v% of sodium azide as a preservative. The K-ASSAY® Ferritin Calibrators (2nd Gen.) are liquid stable products consisting of a human serum matrix and known quantities of human ferritin at 6 levels ranging from 0 -1,000 ng/mL (0, 25, 250, 500, 750, 1,000 ng/mL). The calibrators also contain less than 0.1 w/v% of sodium azide as a preservative.