FDA Approves New Blood Typing Tests
Posted on: Friday, 14 September 2007, 18:00 CDT
The U.S. Food and Drug Administration has licensed 15 new blood typing tests intended to improve the safety of blood transfusion.
The tests, which were previously unavailable in the United States, are known as blood grouping reagents.
The FDA said the tests determine the blood type of blood donors, an essential step in ensuring safe blood transfusion for patients. If mismatched blood is administered to a patient, it may cause a serious and potentially fatal reaction, the agency said Friday in a release.
The newly approved ALBAclone Blood Grouping Reagents include the common ABO and Rh tests, as well as tests for rare blood types. The reagents are monoclonal antibodies, highly specific antibodies that ensure product uniformity and availability.
The reagents are manufactured by Alba Bioscience, Inc. of Durham, N.C.
Source: United Press International
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