In Brief: Gamma Biologicals
This article was originally published in The Gray Sheet
Executive Summary
Gamma Biologicals: Submits 510(k) to FDA for its ReAct gel-based test for the rapid detection of red blood cell antibodies. Consisting of a centrifuge, an incubator and a plastic strip containing an immunoreactive agarose, the ReAct assay's advantages over conventional test tube procedures include ease of use, "stable and reproducible results, fast and short centrifuge time...and clear differentiation between positive and negative results," Gamma says. The company previously has noted that the ReAct technology will cost more per unit than traditional testing methodology but will reduce overall lab costs due to simplified procedures and lower labor costs ("The Gray Sheet" Aug. 21, 1995, p. 11)...