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The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS, the CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING, SEBIA, for capillary electrophoresis. It is used in conjunction with the SEBIA CAPILLARYS PROTEIN(E) 6 kit designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The CAPILLARYS, CAPILLARYS 2 and the CAPILLARYS 2 FLEX-PIERCING perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively . The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins. For In Vitro Diagnostic Use. The IT / IF Control is designed to quality control the qualitative the detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods: - Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2 and CAPILLARYS 2 FLEX PIERCING instruments and on SEBIA MINICAP instrument. - Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, . HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber. The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample. The electrophoretic pattern obtained is specific for each batch of IT/IF control. For In Vitro Diagnostic Use.

This submission includes: - 1) CAPILLARYS IMMUNOTYPING (PN 2100) with the device CAPILLARYS 2 instrument (PN 1222) for serum and urine samples. The CAPILLARYS IMMUNOTYPING KIT was cleared in prior 510K submissions. - 2) IT / IF Control (PN 4788) with the new device CAPILLARYS 2 instrument (PN 1222). The IT / IF Control was cleared in prior 510K submissions. - 3) CAPILLARYS IMMUNOTYPING (PN 2100) with the device CAPILLARYS 2 FLEX PIERCING instrument (PN 1227) for serum and urine samples. The CAPILLARYS IMMUNOTYPING KIT was cleared in prior 510K submissions The configurations of the CAPILLARYS IMMUNOTYPING kits consist of the components summarized in Tables I and II. Additional details are provided in Package Inserts included in Section III of the submission. Each kit with instrument is supplied with Package Insert/manual which contains instruction for use and all the necessary information on the components needed to run the test that are sold separately. Each Package insert also contains information on storage conditions, shelf-life and signs of deterioration of the kit components and the reagents sold separately.

mis kit is intended for separation and/or quantitations of serum proteins and immunoglobulins using agarose gel electrophoresis. mese tests can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflamatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias, genetic deficiencies and gammopathies responsible for multiple myeloma, collagen disorders and other chronic infections.

SPIFETM Electrophoresis System

These kits are intended for separation and quantitations of serum proteins using agarose gel electrophoresis on the REP and REP 3 Analyzer. This test can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflammatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias and genetic deficiencies.

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Bio-Rad Serum Proteins by Capillary Electrophoresis is designed for the separation and measurement of protein fractions in human serum when used with the Bio-Rad BioFocus Capillary Electrophoresis Unit.

The Bio-Rad Serum Proteins by Capillary Electrophoresis is designed for use on the Bio-Rad BioFocus Capillary Electrophoresis Unit. The analytical system, consisting of instrument, CDM software and reagent kit, provides an assay for the separation and percent determination of protein fractions in human serum. Like the Paragon CZE™ 2000 Clinical Capillary Electrophoresis System, Beckman Instruments, (K953077), the Bio-Rad Serum Proteins by Capillary Electrophoresis "Serum Proteins by CE" (SPCE) utilizes the principle of capillary fraction electrophoresis to separate human serum proteins into five distinct bands. The separation is performed at a pH above the isoelectric point of serum proteins, imparting a net negative charge to each protein that is dependent on the difference between the separation pH and the individual protein isoelectric point. When an electric field is applied across the ends of the capillary, the negatively charged proteins and internal marker migrate toward the anode at a velocity dependent upon the ratio of mass to charge. At this pH, the internal surface of the silica capillary is highly ionized, and the presence of positively charged ions in the separation buffer results in a bulk flow of fluid towards the cathode. This electroosmotic flow (EOF) runs counter to the direction of protein migration and is stronger than the anodic movement of the proteins. As a result, the proteins' net motion is towards the detection zone near the cathodic end of the capillary. Measurement of protein absorbance at 225 nm is then achieved through a transparent section of the silica capillary. Sample processing consists of a one step dilution of a senum sample with a diluent containing an internal marker. The prepared samples, up to 28, are then placed into the BioFocus for analysis. A Reference Sample is included as the first sample analyzed in each tray to verify system performance. Proteins are measured, as they exit the cathodic end of the capillary, by direct absorbance of the peotide bond at 225 nm. The Clinical Data Management System (CDM), (K942451), utilizes the time versus signal data along with the internal marker, which is used to convert migration time to electrophoretic mobility, to quantitate the percentage of each of the five protein fractions.