In Brief: Cardiovascular Diagnostics, Inc.
This article was originally published in The Gray Sheet
Executive Summary
Files 510(k) submissions for its Escarin Clotting Time test and Low Range Heparin Management Test. Both tests are based upon CDI's Thrombolytic Assessment System technology, the firm states. The ECT test is intended for use in monitoring the action of Knoll-AG's PEG-Hirudin thrombin inhibitor, for which dosage parameters in the treatment of unstable angina are narrow, the firm explains. The LHMT test is intended for use in measuring heparin levels during cardiac catheterization...