(a) Identification. An automated FISH enumeration system is a ..... system, and customized software applications for FISH assays. This device is ..... intended for in vitro diagnostic use with FISH assays as an aid in the ..... color, size, and shape, and in the detection and enumeration of FISH ..... Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this