ABBOTT PARK, Ill., July 13 /PRNewswire-FirstCall/ -- Abbott Laboratories today announced that its manufacturing partner, Axis-Shield, has submitted a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) seeking clearance of a Testosterone test for use on Abbott's AxSYM(R) automated immunoassay instrument system. In April, Abbott introduced the test in the other major markets throughout the world.
"Expanding diagnostic test menus across our instrument systems continues to be a top priority," said William Brown, Ph.D., vice president, Diagnostic Assays and Systems Development, Abbott Laboratories. "Like other AxSYM assays we've introduced this year, this test increases our AxSYM offerings and will enhance our fertility panel."
The AxSYM immunoassay system can process up to 80 to 120 tests per hour allowing medium-volume clinical laboratories to process a variety of immunodiagnostic tests simultaneously. Besides fertility, other test menus include assays for abused drugs, cancer, cardiac, endocrinology, hepatitis, infectious disease, metabolic/renal, therapeutic drug monitoring and toxicology.
Axis-Shield is a global manufacturer of in vitro diagnostic kits with a focus on new markers in cardiovascular, rheumatoid, infectious and alcohol- related diseases, diabetes, dementia and near patient testing to facilitate improved patient management. Axis-Shield has partnered with Abbott to introduce several new tests on both the IMx(R) and AxSYM(R) systems, Abbott's market-leading automated immunoassay analyzers. News releases and company information are available at http://www.axis-shield.com/ .
About Abbott Laboratories
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.
Abbott 's news releases and other information are available on the company's Web site at http://www.abbott.com/ .
CONTACT: Media, Amy Woodworth, +1-847-935-4755, or Financial Community,Christy Wistar, +1-847-938-4475, both of Abbott