Micronics has introduced a new portable in vitro agglutination test to determine patients' individual blood type and Rh factor from a fingerstick of blood.
The ABORhCard is a qualitative disposable blood typing device which eliminates the need for the instruments or other equipment, liquid typing reagents, and refrigeration traditionally used to determine a person’s blood group and provide results with in two minutes.
Micronics president Karen Hedine said the U.S. Food and Drug Administration has cleared the agglutination test as a 510 (k) Class II medical device for informational and educational purposes.
"While the test cannot be used for blood bank processing of blood products, for determining RHD status for the purpose of administration of Rh immunoglobulin, or for blood screening prior to transfusion, it offers significant benefits, such as informing individuals about their blood type prior to donating blood," Hedine added.
"We believe the ABORhCard is the first test of its kind to undergo extensive U.S. clinical trials
"Micronics enrolled 1,700 volunteers in studies performed by three U.S. blood centers before submitting the 510(k) pre-market notification to the FDA’s Center for Biologics Evaluation and Research."