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Article: Genzyme Receives FDA Clearance for Second-Generation LDL and HDL Cholesterol Tests
- Article from:
- PR Newswire
- Article date:
- September 10, 1997
CopyrightCOPYRIGHT 1997 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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CAMBRIDGE, Mass., Sept. 10 /PRNewswire/ -- Genzyme General's (Nasdaq: GENZ) Diagnostic Products business announced today that it has begun marketing a second-generation homogeneous direct LDL cholesterol test and a second-generation homogeneous HDL test in the United States.
These two product launches follow 510(k) clearance by the U.S. Food and Drug Administration's Center for Devices and Radiological Health to market the tests for in vitro diagnostic use.
The new LDL cholesterol test, called N-geneous LDL, is the only homogeneous LDL test available for sale in the United States. This test and the new N-geneous HDL cholesterol test are simpler and ...