21 CFR 864.9300 - Automated Coombs test systems.
(a) Identification. An automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies bound to red cells. The Coombs test is used for the diagnosis of hemolytic disease of the newborn, and autoimmune hemolytic anemia. The test is also used in crossmatching and in investigating transfusion reactions and drug-induced red cell sensitization.
[45 FR 60646, Sept. 12, 1980]
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.