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The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The Calcium2 assay is an automated clinical chemistry assay. Arsenazo III dye reacts with calcium in an acid solution to form a blue-purplex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample. Methodology: Arsenazo III

Yumizen C1200 Calcium AS reagent is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on colorimetric method, using the clinical chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Yumizen C1200 Creatinine Jaffé reagent is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.

The Randox Calcium (Ca) kit consists of a ready to use reagent solution.

ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings. Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

ELITech Clinical Systems CALCIUM ARSENAZO is available as a kit only. It consists of a mono-reagent R whose composition is: 100 mmol/L MES buffer (pH 6.50), 200 µmol/L Arsenazo III.

ABX Pentra Calcium AS CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on a colourimetric method, using the ABX Pentra 400 Clinical Chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.

All the reagent, controls and calibrator included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer. The ABX Pentra Calcium AS CP is an in vitro diagnostic assay for the quantitative in vitro determination of calcium in human serum, plasma and urine based on colourimetric method. It is composed of a monoreagent cassette (79 mL). The reagent is chemical solution with additives. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml. The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.

Vital Diagnostics Eon Calcium Reagent is a device intended to measure the total calcium level in serum and plasma using the Eon 100 Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

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For in vitro diagnostic use in the quantitative determination of calcium in human serum, plasma, and urine on the ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal failure, and tetany.

Summary and Explanation: the Calcium 2 (CA 2) method is based on the work of Michaylova and Illkova, (Anal Chem Acta 1971; 53: 194), who found that Arsenazo III could form a stable complex with calcium with high selectivity at low pH. Principles of the Procedure: Calcium ions form a colored complex with Arsenazo III, which is measured at 658/694 nm. The amount of calcium present in the sample is directly proportional to the intensity of the colored complex formed. Reaction Equation: Ca2+ + Arsenazo III ---> Ca-Arsenazo III Complex (purple)

The S-Test Calcium Reagent is intended for the quantitative determination of calcium concentration in serum or heparin plasma using the S40 Clinical Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Calcium (CA) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CA in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple complex under strong alkaline conditions.

The Calcium test system is intended for in vitro diagnostic use in the quantitative determination of the calcium concentration in human serum or plasma on T60 instruments. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy. For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy. For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

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For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms). For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL, BUN/CREA, Ca, CHOL, CK, CI, CO2 CREA, CRSC, Fe, GGT, GLU, HDLC, K*, LAC, LDH, LIPA, Mg, Na*, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

The VITROS Chemistry Products Ca DT Slide assay is performed using the VITROS Chemistry Products Ca DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/ DT60 II Chemistry Systems. The VITROS Ca DT Slide is a multilayered, analytical element coated on a polyester support. All reactions necessary for a single quantitative measurement of calcium take place within the multi-layered analytical element of a VITROS Chemistry Products Ca DT slide. A drop of patient sample is deposited on the VITROS Ca DT Slide and is evenly distributed by the spreading layer to the underlying lavers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. In the reagent layer, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum. After incubation, the reflection density of the colored complex is measured spectrophotometrically. The amount of colored complex formed is proportional to the calcium concentration in the sample fluid. The test result is reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/ L). VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.