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The Dimension® Mycophenolic Acid Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Mycophenolic acid (MPA) in human plasma on the Dimension® clinical chemistry system. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic, and cardiac transplant patients. The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid method on the Dimension® clinical chemistry system.

The liquid reagents are configured in an eight well "Flex®"; the content of each Flex® well is described in the Instructions for Use. The methodology for the Dimension® MPAT assay is based on a homogenous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique, which uses a latex particle mycophenolic acid conjugate (PR) and monoclonal mycophenolic acid specific antibody (Ab). Mycophenolic acid present in the sample competes with the mycophenolic acid on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of mycophenolic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm. The Dimension MPAT Calibrator is used to calibrate the MPAT assay on the Dimension system. The calibrator is a five level aqueous BSA matrix product containing Mycophenolic acid. The typical calibration levels for levels 1 through 5 respectively, are 0.0, 0.7, 2.3, 6.7 and 30.0 µg/mL. Level 1 is a zero level, and can be used to dilute samples that exceed 30 µg/mL.

The HbA1c assay used on the Dimension Vista® system is an in vitro diagnostic assay for the quantitative determination of per cent Hemoglobin A1c in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. HbA 1c calibrator is intended for use in the calibration of the Hemoglobin A 1c (HbA 1c) method on the Dimension Vista® system.

The Dimension Vista® HbA1c kit contains Flex® reagent cartridges and calibrator. Each cartridge contains reagents used to measure total hemoglobin and hemoglobin A1c. the reagents are liquid and ready to use on the instrument. The calibrator in the kit is a five level lyophilized product. Each level is hydrated with 2.0mL of reagent grade water. The lot matched reagents and calibrator product are for use on the Dimension Vista Systems.

For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur Systems. Enhanced Estradiol (eE2) ADVIA Centaur calibrator 30 is a device intended for medical purposes for use in Estradiol Assay to establish points of reference that are used in the determination of values in the measurement of Estradiol in human serum, Heparinized and EDTA Plasma.

The ADVIA Centaur Calibrator 30 is a 2 level human plasma based solutions containing varying concentrations of Estradiol in charcoal stripped defibrinated human plasma, 0.1% Sodium azide and preservatives. The Estradiol calibrators have expected values of 35 and 2500 pg/mL. The Cal 30 (2.0 mL/vial) is lyophilized. Storage for lyophilized cal is at 2 - 8°C until expiration date specified on label, reconstituted calibrator storage is at 2-80 up to 14 days, and on board is up to 4 hours.