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Micronics Gets FDA Clearance To Market ABORhCard IVD Test

Micronics has received FDA 510(k) clearance to market ABORhCard, a qualitative in vitro test that provides a simultaneous determination of an individual’s ABO blood group and Rh factor status.

Micronics said that the test is not for use for blood bank processing of blood products but for determining RHD status for the purpose of administration of Rh immunoglobulin, or for screening purposes prior to transfusion. The device is intended for single use for individual blood group determination for educational and informational purposes.

According to Micronics, blood typing typically focuses on determining a person’s blood type (either A, B, AB or O) and Rhesus (Rh) factor. A person’s blood type is based upon the presence or absence of the A and B antigens on their red blood cells.

Karen Hedine, president and chief executive officer of Micronics, said: “The introduction of the ABORhCard provides professionals with access to a credit card-sized device that makes it possible to determine a person’s blood type and Rh status from a finger stick of whole blood, and it provides a visually-read result in minutes.”