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System reagent for the quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum on Beckman Coulter AU analyzers. For In Vitro Diagnostic use only.

The Beta-2-Microglobulin reagent kit is a System Reagent for the Quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum on Beckman Coulter AU analyzers. The ßeta-2-Microglobulin kit is a liquid, ready to use and consists of 4 x 10mL R1 reagent vials and 4 x 8mL R2 reagent vials. Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay. The ßeta-2-Microglobulin reagent is designed for optimal performance on Beckman Coulter AU analyzers.

The kit is intended for the quantitative in vitro determination of beta-2 microglobulin (β2M) in human unne using the SPAPLUS analyser, to aid the diagnosis of active rheumatoid arthritis and kidney disease. The test result is to be used in conjunction with other clinical and laboratory findings

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Reagent: for in vitro diagnostic use in the quantitative determination of β2-microglobulin in human serum or plasma (lithium heparin and potassium EDTA) on ADVIA® 1650 Chemistry systems. The ADVIA 1650 Chemistry 32-Microglobulin (B2M) assay aids in the diagnosis of active rheumatoid arthritis and kidney disease. Calibrators: for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry β2-Microglobulin method.

The ADVIA 1650 Chemistry 32-Microglobulin (B2M) assay sample is diluted and reacted with a buffer that contains latex particles coated with antibody specific for ß2microglobulin. The formation of the antibody-antigen complex during the reaction results in an increase in turbidity, the extent of which is measured as the amount of light absorbed at 545 nm. The ß2-Microglobulin concentration in a sample is determined by constructing a standard curve from the absorbance of a reagent blank and a single-level calibrator. The ADVIA Chemistry B2-Microglobulin Calibrator is a single analyte, lyophilized, buffer based product containing bovine serum albumin and human ß2-Microglobulin. The kit consists of 3 vials of a single level calibrator. The calibrator requires reconstitution with 1 mL of distilled water prior to use.

The B2MIC method is an in vitro diagnostic test for the quantitative measurement of ß₂microglobulin in human serum, heparinized plasma, EDTA plasma and urine using the B2MIC Flex® reagent cartridge on the Dimension Vista® Systems. Measurement of ß 2 -microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease. PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: αγ-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), IS2-Microglobulin (B2MIC, B2MU**), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT),Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG, IGG-C*, ICC-U**), Immunoglobulin G subclass 1(IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF) *For cerebrospinal fluid ** For urine PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® Systems in the quantitative determination of: α-Acid Glycoprotein (A1AG), α-- Antitrypsin (A1AT), a2 -- Macroglobulin (A2MAC), ß2-Microglobulin (B2MIC-U **), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG),Immunoglobulin G subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunodlobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF). *For serum and plasma ** For Urine PROT1 CON M is an assayed, mid-level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: : α -- Acid Glycoprotein (A1AG), α -- Antitrypsin (A1AT), α 2 -- Macroglobulin (A2MAC), ß2-Microglobulin (B2MIC*,B2MIC-U**), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin G subclass 1 (IGG1), lmmunoqlobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR), and Transferrin (TRF), *For serum and plasma ** For urine

Dimension Vista® B2MIC Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration. Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a+acid glycoprotein, a1 -antitrypsin, a1-macroglobulin, 132 -microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunodlobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin. Dimension Vista® Protein 1 Control L: Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : q-acid glycoprotein, α-- antitrypsin, α 2-macroglobulin, ß-microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoqlobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealburnin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin Dimension Vista® Protein 1 Control M: Protein 1 Control M is a multi-analyte, mid level, liquid human serum based product containing: Q -- acid glycoprotein, a -- antitrypsin, as -macroglobulin, 13-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3. immunodobulin G subclass 4. immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor, and transferrin.

The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2microglobulin concentration in human serum, plasma (EDTA) or urine on the AEROSET® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease. The Quantia Beta-2 Microglobulin is intended to be used with the already cleared Quantia PROTEINS Control (K050596) and the Beta-2 Microglobulin Standard (k050613).

The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglubulin concentration in human serum, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease. Quantia Beta-2-Microglobulin reagent was already 510(k) cleared as Quantia Beta-2-Microglobulin for its use with serum and EDTA plasma (K050613). A new submission for the Quantia Beta-2-Microglobulin reagent has been prepared as it is intended to also claim urine as a sample. The kit Quantia Beta-2-Microglobulin already cleared, contained Buffer and Latex Reagent. The Calibrators were already cleared in the submission K050613. There have also been added two different levels of controls in a separate kit. The controls are supplied by Bio-Rad (K851202/A1) and the values are assigned at Biokit S.A. This test with Biokit labeling was cleared k050596.

Dimension Vista™ B2MIC Flex® reagent cartridge: The B2MIC method is an in vitro diagnostic test for the quantitative determination of β2-microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista® System. Measurements of ß2-microglobulin aid in the diagnosis of renal dysfunction. Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the ßmicroglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System. Dimension Vista™ Protein 1 Control M and H: PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of ß2microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.

Dimension Vista™ B2MIC Flex® reagent cartridge: Polystyrene particles coated with specific antibodies to human β2-microglobulin are aggregated when mixed with samples containing human ß2-microglobulin. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration. Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing β2microalobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB). Dimension Vista" Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, liquid, human serum based products containing ß2-microglobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).

The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for The Quantitative determination of beta-2-microglubulin concentration in human serum or plasma the ?? Viro quarklative accension in the diagnosis of active rheumatoid arthritis and kidney disease. Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also 510(k) FDA submitted for use with A1-AT) For in vitro diagnostic use Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.

The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglubulin concentration in human serum or plasma (EDTA) on the AEROSET® instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease. Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also 510 (k) FDA submitted for use with Quantia A1-AT) For in vitro diagnostic use. Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.

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.

This kit is designed for the in vitro measurement of human B2-Microglobulin in serum and urine using the Minineph, to aid in the diagnosis of active rheumatoid arthritis and kidney disease.

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