FDA licenses 15 new blood typing tests
The US Food and Drug Administration licensed 15 new blood typing tests that were previously unavailable in the country.
These tests, known as blood grouping reagents, are used to 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. To prevent such problems, people must receive compatible blood based on the results of blood typing tests.
The newly-approved ALBAclone Blood Grouping Reagents include the common ABO and Rh tests, plus tests for rare blood types. The reagents are monoclonal antibodies, highly specific antibodies that ensure product uniformity and availability, the FDAnotes.
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