Company: Haag-Streit USA Inc. Date of Enforcement Report 7/27//2010 Class ll: PRODUCT UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with DxI System Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations...Read More