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Eurotrol Hct Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. Eurotrol Hct Control is for in vitro diagnostic use only. epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. epoc® Hematocrit Verification Fluids is for in vitro diagnostic use only.

Eurotrol Hct Control and epoc® Hematocrit Verification Fluids are assayed hematocrit reference materials, to verify the precision and accuracy of the epoc@ Blood Analysis System, manufactured by Epocal Inc., Ottawa, ON K1G3P5, Canada, as cleared by FDA, K061597. Eurotrol Hematocrit Control was designed to test the following analytes: Hematocrit. Eurotrol Hot Control and epoc® Hematocrit Verification Fluids electrolyte solutions with conductivity at five levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the epoc Blood Analysis System. Depending the sales unit, 10 ampules of the same level are packed in a carton box for Eurotrol Hct Control, or 5 ampule per level, are packed in a carton box for epoc®Hematocrit Verification Fluids. A product insert with Intended Use is inserted in each product box. The assigned values of each batch are printed on a value sheet as available from the Epocal website: http://www.epocal.com/doc_library.html

Medica EasyQC Hematocrit Control assayed controls are intended to be used to monitor and evaluate the analytical performance of the Medica EasyStat for the measurement of hematocrit by conductivity. For In Vitro Diagnostic Use

Medica EasyQC Hematocrit Control is a specially formulated, two-level, aqueous liquid material intended to monitor hematocrit measurement by the Medica EasyStat analyzer. Medica EasyQC Hematocrit Control provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. Medica EasyQC Hematocrit Control is an electrolyte solution with conductivity at two levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the Medica EasyStat Analyzer. Medica EasyQC Hematocrit Control is a non-hazardous aqueous solution containing no biological materials.

The Aalto Scientific Micro Hematocrit Control are human blood based solutions intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for hematocrit.

The Aalto Scientific Micro Hematocrit Controls are prepared using human blood and chemicals, including less than 0.1% sodium azide as preservative. The Aalto Scientific Micro Hematocrit Controls are for in vitro diagnostic use only. The human components used in the manufacture of the product have been tested and found to be non reactive by FDA approved methods for HIV 1/2, HbsAg HCV and HTLV 1/2.

The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers.

The Chiron Certain Hct is a bi-level quality control material uniquely formulated to provide quality control values for hematocrit analyzers. There are two levels of Certain Hct each provided in 2.5 mL ampules. The product allows verfication of analyzer hematocrit performance within established ranges. Chiron Calibration Vefication Material (CVM™) is formulated to verify the calibration of hematocrit analyzers. The product contains four levels of 2.5 mL ampules and is intended to assist laboratories in compliance with the requirements of calibration verification under CLIA.