Daxor receives FDA approved source for supply of Albumin I-131 after an eight year delay.NEW YORK--(BUSINESS WIRE)--May 23, 1996--Daxor Corp. announced today that it has received confirmation that, after an eight year delay, the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has approved the manufacture of Albumin I-131 by Iso-Tex Diagnostics Corp. of Texas. Albumin I-131 is essential for the measurement of human blood volume. Daxor has worked with Iso-Tex to obtain approval for this isotope. Lack of availability of this isotope has prevented the company from proceeding with the development of its patented Blood Volume Analyzer (BVA-100). The company holds the only U.S. patent ever issued for an instrument used to measure human blood volume. Blood volume measurements are particularly important in the determination of accurate blood loss such as during surgery. The standard blood tests such as the hematocrit Hematocrit Definition The hematocrit measures how much space in the blood is occupied by red blood cells. It is useful when evaluating a person for anemia. Purpose Blood is made up of red and white blood cells, and plasma. and hemoglobin hemoglobin (hē`məglō'bĭn), respiratory protein found in the red blood cells (erythrocytes) of all vertebrates and some invertebrates. measure the thickness but not the volume of blood. These tests are especially inaccurate in situations of sudden blood loss. In contrast, the BVA-100 will provide an accurate measure of blood loss in such patients. Daxor also holds a patent in the European common market which consists of 12 countries and in Japan for the BVA-100. The Albumin I-131 will be used for single use test kits which are used in conjunction with the BVA BVA British Veterinary Association (London, UK) BVA Blinded Veterans Association BVA Board of Veterans' Appeals BVA Bond Van Adverteerders (Dutch Association of Advertisers) BVA British Video Association . The company will now be able to proceed with the final updated 510(k) application for approval of the instrument itself. CONTACT: Daxor Corporation Joseph Feldschuh, MD, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Angela Ramirez, Investor Relations Investor relations The process by which the corporation communicates with its investors. 212/244-0555 |
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