Company:Leica MicrosystemsDate of Enforcement Report 4/1/2009 Class:ll PRODUCT QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035. Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen...Read More

Company:Bio-Rad Laboratories, Inc.Date of Enforcement Report 4/1/2009 Class:ll PRODUCT Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600. Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c, Recall...Read More