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Boule Con-Diff Tri-Level

6 x 4.5mL · Clinical Diagnostic Solutions, Inc.

For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Tri-Level is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.

Details

Device typeFull blood count IVD, control: A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

FDA categoryMixture, Hematology Quality Control

Device ID00812137010216

Catalog number501-605

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone8004533328

Emailquality@cdsolinc.com

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