NEW YORK — Beckman Coulter said on Thursday that it has received 501(k) clearance from the US Food and Drug Administration for its PK7400 Automated Microplate System and related reagents.
The system is designed to perform donor ABO blood grouping, Rh typing including weak D testing, and red blood cell antigen screening, and can be used with specific infectious disease assays. It is designed for use in blood donor and plasma centers, as well as large reference laboratories, and can process 300 samples an hour with a maximum of 12 tests per sample, according to the Pasadena, California-based company.
Beckman Coulter said the system is now available in Europe, Canada, and the US.