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For In Vitro Diagnostic Use. For Professional Use Only. Cystatin C Immunoparticles are intended for the quantitative determination of cystatin C in human serum, heparinized plasma and EDTA plasma by turbidimetry and nephelometry. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. Cystatin C Control Set is an assayed bi-level control intended to monitor and evaluate the precision and accuracy of the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry. The Cystatin C Calibrator is intended for establishing calibration curves for the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.

Cystatin C Immunoparticles are purified immunoglobulin fraction of rabbit antiserum directed against cystatin C covalently coupled to uniform polystyrene particles. The Cystatin C Immunoparticles are provided as a suspension preserved with 15 mmol/L sodium azide and are supplied ready for use. Recombinant human cystatin C produced in E. coli was used as an immunogen for raising the antibody coupled to the polystyrene particles. In the DakoCytomation Cystatin C Assay, human serum or plasma is mixed with the Cystatin C Immunoparticles. The resulting immune complexes are measured by turbidimetry or nephelometry. The generated signal is correlated with the concentration of cystatin C in the sample. By interpolation on a standard curve, the concentration of cystatin C in the sample is calculated. Cystatin C Control Set is a bi-level control. The controls are liquid pools of delipidated human serum enriched with recombinant human cystatin C produced in E. coli and preserved with 15 mmol/L sodium azide. Each donor has been tested and found negative for hepatitis B virus surface antigen, antibodies to hepatitis C virus and human immunodeficiency virus 1 and 2. The Cystatin C Control Set is supplied ready for use. The cystatin C value assignment has been carried out by turbidimetry using the DakoCytomation Cystatin C Calibrator, code No. X 0974, as reference. Cystatin C Calibrator is a liquid pool of delipidated human serum enriched with recombinant human cystatin C produced in E. coli and preserved with 15 mmol/L sodium azide. Each donor has been tested and found negative for hepatitis B virus surface antigen, antibodies to hepatitis C virus and human immunodeficiency virus 1 and 2. The Cystatin C Calibrator is supplied ready for use. The cystatin C value assignment has been carried out by turbidimetry using a precise transfer protocol ensuring traceability to a pure recombinant human cystatin C reference preparation, where the cystatin C concentration was established by dry mass determination.

For in vitro diagnostic use. DakoCytomation Beta-2-Microglobulin Kit is intended for the quantitative determination of beta-2-microglobulin in human serum and plasma by rate nephelometry on IMMAGE® Immunochemistry Systems. Measurement of beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease.

DakoCytomation Beta-2-Microglobulin Kit is an in vitro diagnostic assay device for the quantitative determination of human beta-2-microglobulin. Beta-2-microglobulin (B2M), a low molecular weight polypeptide of 11,800 daltons, is the light chain component of the major histocompatibility antigen (HLA). B2M is present on the membrane surface of all cells that express major histocompatibility antigens and it is normally present in the circulation as a result of cell membrane turnover. The Beta-2-Microglobulin device is similar in design, materials and intended use to other 510(k) cleared devices, which are in commercial distribution.