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Article: Abbott and Axis-Shield Announce US 510(K) Submission and Non-US Launch Of AxSYM(R) BNP Test for Heart Failure.
- Article from:
- PR Newswire
- Article date:
- December 8, 2003
CopyrightCOPYRIGHT 2003 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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ABBOTT PARK, Illinois, December 8 /PRNewswire/ -- - Elevated Levels of B-type Natriuretic Peptide (BNP) are Associated with Cardiac Dysfunction or the Severity of Heart Failure
Abbott Laboratories today announced that its manufacturing partner, Axis-Shield, has submitted a Premarket Notification 510(k) Application with the U.S. Food and Drug Administration (FDA) seeking clearance of a B-type Natriuretic Peptide (BNP) test for use on Abbott's widely used AxSYM(R) automated immunoassay instrument system. BNP is a cardiac marker used in the diagnosis of heart failure.
In November, Abbott introduced the test in major markets throughout the world, except ...